AKBA - NASDAQ

Good day, and welcome to Akebia's Fourth Quarter 2024 Financial Results Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I would now like to turn the call over to Mercedes Carrasco, Senior Director, Investor Relations. Please go ahead.

Thank you, and welcome to Akebia's fourth quarter and full year 2024 financial results and business update conference call. Please note that a press release was issued earlier today, Thursday, March 13, detailing our fourth quarter and full year 2024 financial results, and that release is available on the Investors section of our website. For your convenience, a replay of today's call will be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer; Nick Grund, Chief Commercial Officer; and Erik Ostrowski, Chief Financial and Business 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 financial results, press release that we issued on March 13, as well in the Risk Factors and Management Discussion and Analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes, and thanks to everyone for joining us this morning. Well, it's March 13th, which is World Kidney Day. As a company whose mission is to better the lives of people impacted by kidney disease, this holds a special meaning. One of the enduring themes of World Kidney Day is driving innovation in the care of kidney disease. I am proud of the role Akebia plays and will continue to play in delivering that innovation. As a matter of fact, as you know, we are just in the early days of bringing an important new treatment to the care of patients on dialysis. It is a pleasure to have the opportunity this morning to discuss the excellent progress we've made in the launch of Vafseo, our HIF-PH inhibitor for the treatment of anemia due to chronic kidney disease for patients on dialysis. We're in the earliest stage of our launch. The data we will review today represents the first-seven weeks of prescribing. And of course, there's always some volatility at this stage. But even at this early stage, we're very excited about what we're seeing in the market. Now let me be clear, we do not plan to provide quarterly revenue guidance going forward, but we thought it was important to share early performance metrics, especially, since we have only about two weeks left in the quarter. With that said, I am very pleased to report that we expect $10 million to $11 million in net product revenue for Vafseo in the first quarter, a very strong start and well ahead of current analyst estimates. Our goal is to make Vafseo standard-of-care for patients with anemia due to chronic kidney disease. That goal has two parts: first, a successful dialysis launch; second, an approval of Vafseo for the non-dialysis patient population. I'll address both, but let's drill down on the launch first. Previously, I outlined the three initiatives we had to execute to work towards a successful launch and sustained growth, trade access through effective contracting, drive demand at the prescriber level and generate data to identify potential additional benefits. When the first prescriptions were written for Vafseo on January 13th, we had commercial supply contracts in place with the dialysis providers who care for nearly 100% of dialysis patients in the U.S., which we believe is a first for a drug with transitional drug add-on payment adjustment or TDAPA reimbursement. Of course, having a contract in place is just the first step to broad access. We have also worked with the dialysis organizations to have protocols in place and finalize other operational elements like, distribution and ordering details. We've been successful working through this process in many dialysis organizations, and these are the DOs driving early prescribing. For some time, we've said we expect our early use in adoption to come from the medium and small dialysis organizations, who care for about 150,000 patients collectively. This has been the case and an appropriate area of focus, but we're also pleased with the progress we're making across the broader market. Now access with our corresponding prescriber demand does not get product to patients. If you recall, as we prepared for product introduction, I spoke about the coiled spring strategy. Secure contracts and build prescriber demand to start transitioning patients on to Vafseo as quickly as possible upon availability. I believe that strategy is playing out in the excellent pull through to patient prescriptions we've seen in the early launch metrics. Nick will give you a sense of both prescribers and prescriptions through the end of February. With the pieces for a successful launch in place and impressive early traction, our team also focused on the third initiative, continuing to build evidence is what we believe ultimately allows a product to become standard-of-care. The VOICE study in collaboration with U.S. Renal Care is an important effort to generate significant data potentially demonstrating additional benefits of Vafseo treatment. Positive results from VOICE would potentially show a significant reduction in hospitalization versus ESAs, data that we believe will be critical for physicians as they make anemia treatment decisions. Dr. Block, the lead investigator began study enrollment at the beginning of December. And as of last week, he has enrolled over half of the total target of 2,200 patients. Finally, to become standard-of-care for all patients with anemia due to CKD, we need to be able to have the product approved for the non-dialysis population. I was in the field with one of our key account managers on day last month and every physician I spoke to proactively told me that they wanted to use the product for their NDD patients. We plan to work to enable them to do that as quickly as possible. Now in our latest communication from the FDA, they offered the opportunity to meet with them to discuss the protocol for our planned Phase 3 clinical trial, VALOR, which will study the use of vadadustat in treating anemia in late-stage CKD patients, who are not on dialysis. We believe taking the time for this meeting will be helpful to the success of the program in the long run. We expect to initiate the VALOR study in U.S. non-dialysis patients in the second half of this year. We will continue to update you as appropriate as we get closer to initiating this important study. Treatment of non-dialysis patients is clearly a significant potential opportunity for Akebia and for patients, and it's a primary focus for our development organization. In parallel, our commercial organization is completely focused on dialysis launch success. Now let me turn it over to Nick to give more details on the early days of our launch.

Thanks, John. Good morning, folks. Let's start with the headlines for the Vafseo U.S. launch. Demand is extremely strong. We have seen the number of prescribers and prescriptions increasing throughout the quarter, and we expect between $10 million and $11 million in Vafseo net product revenue for Q1 2025. I'm pleased with the early traction, especially considering the market dynamics we've seen early in quarter one. With the transition of binders in the bundle, including our own Auryxia no longer are a majority of patients filling prescriptions at retail pharmacies. Going forward, the large majority of prescriptions are going to be shipped directly to the patient's home. To enable this change, many of the dialysis organizations, let's now partner with a specialty pharmacy provider. Thus far, in quarter one, we are seeing prescription demand for all TDAPA products, including Auryxia and Vafseo outstrip capacity at specialty pharmacies. In some cases, with a backlog for binders and Vafseo exceeding three weeks. However, because we already have a robust distribution network, we were able to work with customers to find capacity. This backlog is starting to subside, but I believe that our customers and patients felt the negative impact. Now let's get into some of the underlying launch details in demand. Since approval, we spent a lot of time discussing the importance of strategy focused on creating broad access and driving prescriber demand for Vafseo. It is good to see that strategy translate into market activity. In terms of access, we began shipping Vafseo on January 9th. We had contracts in place with dialysis organizations caring for nearly 100% of patients. And I'll reiterate that the need for DOs to contract for phosphate binders, including Auryxia, helped our team get to the table to contract for Vafseo at the same time. To build demand since approval, our key account managers have worked hard to educate prescribers on the unique attributes of Vafseo and work with them to help identify patients that may benefit from Vafseo therapy. Importantly, these demand building discussions turn to action. I'd like to focus first on the physician reception now that Vafseo is available for prescribing. As we expected, home patients and those patients on higher doses of ESAs were some of the earliest patients prescribed Vafseo, but we've also seen use more broadly with in-center patients. We believe prescribers will continue to expand utilization of Vafseo in these patient groups after gaining experience with the product and seeing the benefits of Vafseo for these initial patients. More broadly, it is clear, physicians are excited to have an alternative therapy to help manage anemia in their CKD patients. The enthusiasm has been demonstrated not only through their interaction with our sales team, but is also tangible through our peer-to-peer programs. To date, since launch, we have had over 70 peer-to-peer programs where key medical experts, or KMEs educate their peers on Vafseo. While the number of programs is as impressive, it is the attendees level of interest and the engaged dialogue that reinforce the opportunity for Vafseo. In these programs, not only are we seeing strong HCP attendance, but we're also seeing broad attendance by the entire dialysis clinic care team, including prescribers, anemia managers, nurses and billing and coding personnel. This reinforces our premise that anemia management is an important component of caring for CKD patients on dialysis and that an alternative therapy to ESAs is highly desired. Again, the interest is turning into action as physicians tried Vafseo for various patients. Early in the launch, we want to gain breadth of prescribing. Then as we move past the trial phase, we want to drive depth, resulting in greater volume of prescriptions among our physician targets. I'd like to share with you some insights and metrics we're watching closely to monitor our launch progress. As expected, it's the small to mid-sized dialysis organizations that are driving revenue. Through the end of February, USRC has been our largest customer. USRC serves approximately 36,000 patients across the U.S. While USRC is certainly an early adopter, other dealers are also purchasing. We are pleased to report that we have sales to three of the top four dialysis organizations. The larger organization that purchased still has work to do in operationalizing a protocol, which once implemented should enable broad prescribing, but it appears they are willing to make the product available to patients in need on a medical exception basis now. In addition, we have a number of independent and small dialysis organizations purchasing Vafseo because of our robust distribution network and our direct contracts with dialysis organization, we understand the product supply channel extremely well. This allows us to highlight that there are currently approximately three to four weeks of inventory in the channel. At the prescriber level, from January 13 through the end of February, over 500 physicians have prescribed Vafseo with an average of approximately eight prescriptions each. Of course, there is various levels of prescribing from physicians, ranging from those with only one prescription. So those that have as high as 64 prescriptions since January 13th. These data tell me that our team has engaged with our highest priority prescribers, and those prescribers are very willing to try Vafseo for their patients. Importantly, of those physicians prescribing greater than 50% of them care for patients within other dialysis organizations in addition to caring for patients at USRC clinics. This gives us confidence that has the breadth of dialysis organizations that are fully operational expands meaning protocols and other logistics are in place for the sale of Vafseo. The physician should be able to leverage their treatment experience across a number of organizations to drive depth of prescribing. Moving from physician demand and prescribing, I wanted to spend a moment highlighting some early reimbursement trend. As we previously discussed, we have been focused on access for Medicare fee-for-service patients as these patients have immediate reimbursement for TDAPA drugs. We also indicated that we expect Medicare Advantage coverage where dialysis organizations have contracted with Medicare Advantage plans for TDAPA like or innovation payment. For instance, in February alone, we have seen a greater than 15% of prescriptions have been written for payers other than Medicare fee-for-service. This is an encouraging sign that even early in March some Medicare Advantage plans are already covering Vafseo. We're extremely enthusiastic about the initial indications of demand for Vafseo and look forward to updating all of you on our next call. Let me now turn it over to Erik.

Thank you, Nick. After John and Nick's comments, we're very excited about our prospects in 2025 and are encouraged by what we've seen thus far with the launch of Vafseo in the U.S. I'll now provide an overview of our fourth quarter and full year 2024 financial results as compared to the prior year. Total revenues, which are comprised of net product revenues as well as license collaboration and other revenues were $46.5 million and $56.2 million in the fourth quarter of 2024 and 2023, respectively, and $160.2 million and $194.6 million in 2024 and 2023 respectively. Of these amounts, Auryxia net product revenues were $44.4 million and $53.2 million in the fourth quarters of 2024 and 2023, respectively, and $152.2 million and $170.3 million in 2024 and 2023 respectively. These decreases were primarily driven by a reduction in volume, partially offset by price increases and execution of our contracting strategy in the third-party payers. As a reminder, in late March 2025, Auryxia will lose [indiscernible]. License, collaboration and other revenues were $2.1 million and $3 million in the fourth quarter of 2024 and 2023, respectively, and $8 million in 2024 compared to $24.3 million in 2023, which included a one-time $10 million license agreement related to upfront payment. Cost of goods sold was $20.4 million and $18.7 million in the fourth quarter of 2024 and 2023, respectively, and $63.2 million and $74.1 million in 2024 and 2023, respectively. In the full year 2024 and during the fourth quarter of 2023, we realized a $12.3 million benefit, a $4.3 million benefit, respectively, due to our ability to sell inventory previously written down to excess inventory. In addition, the decrease in cost in both period-over-period comparisons reflects lower Auryxia sales volumes in 2024 as compared to 2023. R&D expenses were $11.8 million and $9.9 million in the fourth quarters of 2024 and 2023, respectively, and $37.7 million or $53.1 million in 2024 and 2023, respectively. The quarterly increase was driven by expense related to the amendment of our license agreement with Cyclerion. The yearly decrease was driven by the completion of activities related to certain clinical trials, lower headcount related costs and decreased professional services and consulting expense. SG&A expenses were $27.7 million and $25.4 million in the fourth quarters of 2024 and 2023, respectively, and $106.5 million and $100.2 million in 2024 and 2023, respectively. These increases were driven by costs incurred in connection with preparatory activities related to the Vafseo U.S. launch. Net loss was $22.8 million in the fourth quarter of 2024 compared to net income of $0.6 million in the fourth quarter 2023. Net loss was $69.4 million in 2024 compared to $51.9 million in 2023. The increases in net loss were impacted by lower period-over-period revenues as well as by non-cash interest expense occurred in 2024 related to the settlement royalty liability in connection with the July 2024 Vifor termination settlement agreement, which was $4.9 million in the fourth quarter of 2024 and $9.3 million for the full year 2024. Cash and cash equivalents as of December 31, 2024 were $51.9 million compared to $42.9 million as of December 31, 2023. We expect this cash and cash from operations will be sufficient to fund our current operating plan, including planned pipeline advancement for at least two years. Post year-end, we further strengthened our financial position by raising $18.4 million in net proceeds from sales under our ATM facility, including the sale of shares to top tier health care specialist investors, which we believe has helped increase institutional sponsorship of Akebia stock. In addition, on February 3, 2025, we elected to draw down Tranche C of our BlackRock Credit Agreement, resulting in net proceeds of $9.3 million. With that, we welcome questions.

Thank you. [Operator Instructions] Our first question comes from Allison Bratzel with Piper Sandler. Your line is open.

Hey. Good morning, guys. Thanks for taking the questions. Just a couple for me. First, I think you touched on this in the prepared remarks, but does that Q1 Vafseo revenue include any stocking or inventory build? Second, just what are you seeing in terms of dose frequency, particularly for those in-center dialysis patients daily, 3 times weekly? And third and last, can you just talk about how protocolization is gaining uptake at large scale dialysis orgs and just how long until you think you see uptake at those LDOs? Thanks.

Great. Thanks, Ali. So first was Q1 revenue and stocking. Yeah. I mean this is obviously -- you have your first quarter as when they do need to put inventory and Nick referenced that we expect them to stay in the two to four week range of inventory. And remember, this has been a retail product. So you're not putting it into the wholesaler and the retailer. It's kind of one-stop to the specialty distributor, and it goes from there. So we have a very, very good handle on that. But in that revenue guidance, there will be a little bit of inventory, that's part of it. So on the dose frequency side, this is -- I mean, it's almost all 2D use today. I mean there are some that are starting their protocols, some smaller centers that are starting the protocols with TIW dosing, but certainly, U.S. Renal, for instance, it's a QD dose protocol that's in place. Anything on that to add Nick?

No, I think you had all. Yeah.

And the protocolization, so as we said, I mean, this is what takes -- you get the contract in place, then you've got to get a protocol in place. And beyond the protocol, you've got to get all the operational details. One of the ways, I've been describing it is that kind of the distance between the person who signs the contract and the person who writes the prescription, the shorter that distance, the faster they can move and that is clearly the case. It is -- so if you think about one of the LDOs who has ordered product, while they have a protocol written, getting it operationalized into their myriad of systems, etc., is simply taking longer than we like. And it's hard to say exactly how quickly they'll have it up and running. I mean I think the -- there's an understanding of the value of having the product available. There's a desire from the physicians to write it. And then there's all the bureaucracy that goes in between that gets it up and running. We've talked about kind of the first half of the year really being driven by the small and medium providers. I mean there's 150,000 patients there. And we feel that, that can make most of the year. But I think as we get into the second half of the year, we want to see more movement at the larger providers. And we expect we will, based on the conversation we've had, at least with the -- certainly with the one. The fact that they are allowing the product for patients that they identified or prescribers identify as high need is great, right? I mean it’s a start. It gets people experienced with the drug. They know they want to make the product available. They just make that available outside of their systems that they have to have in place to make this available broadly at the deal.

Excellent. Thank you.

Thanks, Ali.

Thank you. Our next question comes from Julian Harrison with BTIG. Your line is open.

Hi. Good morning. Thank you for taking my questions. First, Nick, I think you mentioned in your prepared remarks a recent backlog in Auryxia. I'm just wondering, if you could expand a little bit more on that. Has demand for Auryxia now with TDAPA Online maybe exceeded initial expectations. Am I understanding you correctly there?

Yeah, Julian. It's a great question. I just want to be really clear. The backlog was for all phosphate binders and Vafseo, not just Auryxia and Vafseo. And it's really when a lot of the prescriptions were being filled at the retail pharmacy, there was enough stocking in inventory. Patients would go to the 10,000 or so retail pharmacies in the U.S. to pick up the prescription. On January 1st, all of those moved into specialty pharmacy for the most part. And the specialty pharmacy providers frankly, didn't have the capacity. And so, if you think about the intake process, the prescription for a patient, that prescription has to be loaded into a specialty pharmacy system. They've got a check insurance. They've got to do all that verification that goes around with a prescription. And in some cases, they got 20,000 prescriptions in the first 15 days of the month. And so that inflow of heavy effort level prescriptions caused the backlog across the board. As a reaction, what we had done is with a broad distribution network, we said, let's move our customers around, in some way, shape or form to be able to help them get to the capacity and therefore, fill the prescriptions. And so, while we'll call it in that month of January, maybe early February, we're in this kind of 20 to 24 day backlog, that subsided substantially for our products over the course of the quarter. And then we think that it's down in this kind of five day range today, but it didn't impact all folks who have a TDAPA product in quarter one.

Okay.

And it's important to point out that we're focused on those small and medium-sized providers today, and it was really the smaller providers who kind of kept waiting and hoping that the legislation was going to pass to keep the binders out of the bundle. So they just weren't operationally ready as we were trying to push them to be. And so I do think they appreciate the help that we're giving them now and only kind of increases outstanding with them. But again, the demand is there, and you're seeing the demand. You work through operational issues, and I think it bodes well for the growth of the product.

Okay. Got it. Thank you. That makes a lot of sense. And then I'm wondering if you could just talk a little bit more about the timing of your next regulatory interaction for initiating the VALOR study back half of this year. And I'm just wondering, are you really just seeking alignment on study design at this point? Are there any other open questions?

No. I think it is really about study design. And we look at the communication that we've gotten from them is kind of quite a positive light. As I've said before, I mean, they communicated that they see a significant unmet need for an oral therapy to treat patients with non-dialysis patients anemia, right? That's significant change from where they were 10 years ago. And with that, the opportunity to go and meet with them and talk about I think, we want to get started as quickly as we can. There's no question about it, but it's not when you start, it's when you finish, right? And the idea that we have this conversation, find opportunities to actually speed the program, speed the program up from where we are. It’s just too good to pass up. So exactly when that – we expect that will be a Type C meeting when we meet with them. And we haven’t sent that meeting request in now. We’re kind of working through the what you have to send that in. So we’ll give an update and we know more as appropriate. But obviously, we’re looking to do all of this as quickly as we can. But again, speed, but you really want to take advantage of the opportunity they’ve given us here.

Excellent. Thank you.

Thanks, Julian.

Thank you. [Operator Instructions] Our next question comes from Ed Arce with H.C. Wainwright & Company. Your line is open.

Hey. Good morning, guys. Congrats on the first couple of months of your launch. Thanks for taking my questions. Firstly, -- yes. I joined a couple of minutes late. So I just wanted to see if I could have you go through quickly the launch metrics that you plan to disclose on a quarterly basis? And then I have a couple of follow-ups.

So let's talk about what -- I'll have Nick kind of go through again what we provided. And I think that, that idea of kind of prescribers and average prescriptions is something that will be really helpful in your kind of following the progress we're making. So Nick, do you want to review that again?

Yeah. And so what we had talked about was over 500 physicians prescribing through the end of February with an average prescription level at about eight prescriptions per prescriber. And there's a broad range. And so we have a number of physicians that are still prescribing just one prescription. And we also have prescribers that are prescribing as high as 64 prescriptions. And so we're seeing good breadth of prescribing and some depth early on. And I think we need to continue to drive that. We've seen acceleration of prescribers and prescriptions throughout the quarter. So we're in that kind of arrow pointing to the upper right, which is awesome. But there's still work to do, and there's still a lot of opportunity out there, and we're going to capitalize that in the coming months and quarters.

I think when you see someone writing one or two prescriptions that’s trial, even eight on average is really encouraging. As a matter of fact, in one of the most recent launches in dialysis was -- which I think is considered a pretty successful launch is Vafseo (ph) and different markets, but both in dialysis, it might be interesting to see what their kind of first-seven weeks or so of results were.

Yeah. And John said it well as we looked around for comparators, let's be honest, there hasn't been a lot of successes recently in dialysis and but Vafseo (ph) is one that kind of stands out comparatively, if you look at their first seven or eight weeks of their launch, their number of prescribers is about half of what we have for prescribers. And so as you look at kind of trajectory, it looks like comparatively, we're off to a faster start in terms of driving that trial broadly among prescribers.

Okay. Great. And then just as you think about -- just as I'm thinking about the progression throughout this year as you transition from as you said, mostly the small and medium deals for now and then the larger LDOs in the second half of the year. Just wondering -- first, on gross to net, what is that looking like right now in the early initial months? And where would you expect it to be steady state? And also the split between commercial and Medicare -- what is that looking like now? And then ultimately, where would you see it settling out steady state? Thanks.

Do you want to talk about the commercial to Medicare piece?

Yeah. And certainly, we're seeing, we'll call it good uptick in Medicare Advantage plans. If you recall, Ed, that we had really two major portions. Medicare and Medicare Advantage patients represent a vast majority about 80% of the total patients are in that bucket. And it's split about half and half between what we call typical Medicare fee-for-service and patients that are Medicare Advantage. Medicare fee-for-service, we have immediate reimbursement and then the deals will have immediate reimbursement for the patients that they put on Vafseo. Medicare Advantage, the DOs would need to contract with Medicare Advantage plans to be able to make sure they get a TDAPA like or an innovation payment associated with new products. And so we are seeing obviously immediate reimbursement on the fee-for-service side. On the Medicare Advantage side, we're actually really encouraged that about 15% of all the prescriptions we've seen are for our Medicare Advantage patients, which means the DOs have been successful to some extent in contracting with those Medicare Advantage plans. And so that bodes well for additional addressable populations that can get access to Vafseo as we move forward. When we think about the commercial plan, the commercial folks are actually a really small percentage. We have seen selective commercial reimbursement, but the commercial patients are such a smaller portion of the overall dialysis population when compared to Medicare Advantage and Medicare.

Yeah. I think if you focus on that 80% to 85% of the population that's Medicare, and as we've talked in the past, we've always told you, look, to be most conservative, just focus on patients who have TDAPA, free-for-service TDAPA payment, which is half of your Medicare population. We're really encouraged by the fact that in the first couple of months, we're seeing 15% of prescriptions come through outside or beyond fee-for-service, that's a really good leading indicator. We've always believed that you would get more. Remember, the MA contracts are not ours, they're the dialysis providers. So the fact that they're getting access and again, I mean, these are the smaller providers, we think the larger providers have even better access, and it really does bode well for kind of the total addressable market for the population ultimately. And the other question you asked was about gross to net. So we're not providing gross to net on the call. A couple of things just to help get you there. The average virtually all of the prescriptions written were kind of for that starting dose, which is 300 milligrams, and that's a bottle, right? So that's $1,278 per bottle is the WACC for that. The reason we're really cautious about providing it most of the discounts then comes from our contracts. We talked about our contracts having a small off-invoice discount and then a volume-based discount. And that as their volumes grow, that discount will grow as well. And over time, our gross to net will decline. So you can interpret that it's a bit higher now. Even as different providers come in, you might see some fluctuation in that. The other thing to remember, these prescriptions are all being written for that starting dose. We know from our clinical studies that the average dose that patients have to take was about 400 milligrams a day. So about a third higher than what you're seeing in the prescriptions today. So as we move forward, you're going to see this discount for the rebates. But I think you'll also see some offsetting growth in the size of a prescription in the dose. I know it doesn't give you everything you need, but it's -- hopefully, it helps a bit.

Yeah. No, that's great, John. Appreciate the detail there. And then, maybe just one more, if I may on VALOR. I know you're seeking to get prepared for this meeting and the opportunity there to seek alignment. What portions of the study design that you're seeking, can you share with us today? And do you think the cost of that study is embedded within your current run rate? Thank you.

Great question, Ed. So the last question is definitely yes. The cost is embedded in our runway discussion. It is part of our base operating plan. And again, we expect to be able to run this trial more efficiently given there aren't two other products out there trying to enroll studies. We have a commercial product will be for dialysis. So there's a higher level of comfort. We're focusing on nephrologists versus kind of a lot of primary care in the initial PRO2TECT (ph) study. So we really think we can do this in an efficient from a financial perspective in a quick way. What we've talked about before is, we're looking to do this as a -- with a standard-of-care comparator and kind of discussing with the agency, the -- how we'll analyze that data and how you kind of will look at that. I think, again, getting that agreement or at least kind of having that discussion upfront will definitely be helpful as they're reviewing the drug later on. So I think it's a lot about that, like the analysis plan and using a standard-of-care comparator because remember, the U.S. data from PRO2TECT, which had over 1,700 patients demonstrated that there wasn't an increased MACE risk, that had a darbepoetin control, right? If this has got a different control, understanding how we're going to do that analysis and how they're going to analyze the data and doing that upfront, I think we can make the tweaks to the protocol that would be helpful for them. If we can do that now, it obviously is a lot more efficient than if we had to do it down the line, like we waited a year before we talk to them about the SAP. So -- and I think all of that -- I don't know, I'm just encouraged by the fact that they're -- and they really do seem to want to help see us succeed. We have to execute the trial, right? But we're encouraged at this point with their engagement.

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to John Butler for any closing remarks.

Michelle, thank you so much. Thank you all for the questions and for your time this morning. Our Vafseo launch is going extremely well. We're committed and focused on the work to make Vafseo standard-of-care for treating anemia due to CKD. In kidney month and throughout the year, it's our patience and our purpose that motivate us to continue our pursuit. We look forward to updating you on our progress in May on our Q1 call and seeing many of you during investor meetings later in the year. Thanks, everyone, and have a good day.