Ladies and gentlemen, thank you for standing by. Welcome to Akebia conference call. 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 would 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 like now to turn your conference over to Mercedes Carrasco, Senior Director, Investor Relations. Please go ahead. Thank you, and welcome to Akebia's Commercial Update conference call. Please note that a press release was issued today, Thursday, July 11, and that release is available on the Investors section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, and Nicholas Grund, Chief Commercial Officer. We also have Erik Ostrowski, Chief Financial Officer and Chief Business Officer, joining and available for questions. 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 July 11th, as well as in the Risk Factors and Management Discussion and Analysis section of our most recent annual and quarterly reports filed with the SEC. The forward-looking statements on this call speak only as of 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, everyone, for joining us this morning. It's great to be here today to provide you with some important updates on our ongoing Vafseo launch. Now, we're going to cover a lot of ground today. First, I'll review positive changes to our relationship with CSL Vifor. Then Nick will discuss our WAC pricing decision, TDAPA filing, and progress on contracting for both Auryxia and Vafseo. We are very pleased with the progress we've made in just three months. As I've previously outlined, our launch is centered around three initiatives. First, driving prescriber demand; second, effectively contracting with dialysis organizations; and third, generating clinical data to identify additional areas of potential benefit to patients to ensure long-term growth and move Vafseo towards being the oral standard of care for patients on dialysis. Now, we're making great progress on our third medical initiative, but today we want to focus on the progress we're making on our commercial initiatives to drive prescriber demand and contract effectively. In a moment, I'll turn it over to Nick to discuss the significant progress we've made in these areas of the launch. But first, I want to review an important and positive change to our relationship with CSL Vifor that will streamline our launch initiatives. Today, we announced that we've created a new structure to our relationship with CSL Vifor, terminating our license, our license agreement and putting a royalty agreement in place. We believe this change will significantly simplify our operational approach to market access, which we believe will facilitate and accelerate the contracting process and all other aspects of a successful launch. With the royalty-based termination agreement, we regained full rights to Vafseo in the US, and in exchange, we'll pay CSL Vifor tiered royalties on Vafseo US net product sales. The details of the agreement are available in the 8-K that we filed today. But to summarize, all Vafseo annual net product sales under $450 million will be subject to a high single-digit royalty to CSL Vifor. Vafseo annual net product sales over $450 million will be subject to a mid-single-digit royalty. Now we have the option to buy down the royalty at any time, beginning in July 2027. If we execute the buy down option, the new royalty structure would be a mid-single-digit royalty up to $450 million of Vafseo annual net product sales, and there'd be no royalty on annual Vafseo sales over $450 million. The buy down option and the new agreement overall is a reflection of the very significant value we believe is possible for Vafseo. We separately recall that in May of this year, we revised the license agreement with CSL Vifor to modify the method of repayment for the working capital fund through tiered royalties to CSL Vifor, based on Akebia's net sales of Vafseo in the US. Those repayment terms are simply carried over into this new termination agreement. CSL Vifor has been a great partner over the past years. We appreciate that when we approached CSL Vifor to discuss the royalty-based termination agreement, the company was agreeable to a simplified arrangement. They've contributed significant capital to getting Vafseo to market, and under the agreement, have the opportunity to generate a return on that investment, while at the same time, Akebia achieves economic and, most significantly, operational benefits. We look forward to operating under our new relationship with CSL Vifor moving forward. Now, with that, I'd like to pass it to Nick to discuss overall launch progress. Nick? Thanks, John, and thank you all for joining the call. ... It has been three months since Vafseo approval, and our launch is in full swing. We're all pleased that the market reception has been strong. It is clear that prescribers are looking forward to having a new tool to manage anemia for dialysis patients. To highlight some recent accomplishments, we have seen unaided awareness of Vafseo increase approximately 60% since the time of approval. Additionally, prescribers are eager to learn more. We have accelerated our Vafseo messaging, moving beyond general awareness of the product and label, to educating prescribers on the clinical aspects of the product. We validated our presumptions that physicians have patient populations in mind for first experience with Vafseo. We continue to hear that upon availability in January, prescribers are willing and eager to begin to adopt Vafseo in home or peritoneal dialysis or PD patients, and in patients treated in-center who are on high doses of ESAs, as well as those patients who are not achieving appropriate hemoglobin levels. These segments represent a very large opportunity for Vafseo in Akebia, and our clinical evidence strongly supports treating these patient population subgroups. Recall, our pivotal INNO2VATE studies were published in the New England Journal of Medicine in 2021, and we have a robust publication plan in place. Efforts to drive prescriber demand will continue through for the product availability in January 2025 and beyond. Driving prescriber demand is as important as effective contracting to make Vafseo available to patients. As part of the contracting process, we set price, and to be eligible for reimbursement, we filed our Transitional Drug Add-On Payment Adjustment, or TDAPA application in June and expect TDAPA designation in January 2025. Vafseo is a unique product based on Nobel Prize-winning science, and that we believe meaningfully changes today's treatment paradigm of anemia for dialysis patients and for physicians who are used to using injectable ESAs. As a once-daily oral tablet that activates a physiologic response for anemia management, we believe Vafseo clearly brings significant value to a space where innovation was previously lacking. Today, we announced our Vafseo wholesale acquisition cost at $1,278 per 150 mg, 60-count bottle, or approximately $15,500 per patient per year, based on the starting dose in the label. We have tested this pricing level with our stakeholders and believe that it will be compelling to physicians and dialysis providers operating in the TDAPA environment who want to use Vafseo. The price reflects the value we believe Vafseo can provide to dialysis patients upon market availability, as well as the potential value we believe is possible for a pre-dialysis CKD population, if approved. Our expectation is that our medical and regulatory teams will engage with the FDA this year on a path forward to potentially making the product available for non-dialysis patients. We expect we would be reimbursed by Medicare Part D and commercial plans. This was an important consideration when making this strategic pricing decision. We're extremely pleased with the progress we've made towards contracting the product portfolio with dialysis organizations. Our existing renal-focused commercial team is in place and has extensive experience contracting in this space, as demonstrated by the fact that we already have an existing Auryxia contract in place with one of the largest dialysis organizations in the U.S. that extends through to 2024. We know how to contract efficiently and effectively. The relationships and contracting expertise is broad-based across all dialysis organizations and while will now be focused on the entire portfolio. We believe we have the key building blocks in place to contract Vafseo prior to product availability and Auryxia prior to the start of TDAPA, namely the people and our portfolio. There is significant value in the portfolio. Auryxia is entering the dialysis bundle in 2025, which has allowed us to start having conversations, and importantly, contracting with dialysis organizations or DOs, and it has yielded two benefits. First, it reaffirms that the pricing structure and strategy in place for Auryxia, which will serve as the basis for a similar structure and strategy anticipated for Vafseo contracts, is solid. Second, it reaffirms DO's desire to contract directly with Akebia around our portfolio. Our credibility is further demonstrated today by noting that we signed our first multiyear Auryxia TDAPA contract, which starts in 2025 with one of the largest DOs in the U.S. This first contract serves as a springboard to engaging further with all DOs around the portfolio. In coming months, I look forward to updating you on the progress on the percent of patient lives managed by DOs under contract for both Auryxia and Vafseo. As a reminder, as we discussed in previous calls, our product supply contracts with dialysis organizations will include an off-invoice discount and a volume-based rebate, meaning as volume of Vafseo is purchased by DOs goes up, the net price goes down. We've had many conversations with DOs about this structure, which is the type of familiar arrangement they anticipate and welcome. Dialysis organizations are looking for two major items in these agreements. First, economics during TDAPA to cover the operational costs associated with Vafseo availability. Second, predictability throughout the term of the agreement to allow for them to prescribe products without the fear of having to switch patients at a later date. In January, when the product is available, we expect to see net pricing to reflect the off-invoice discount and a rebate reflective of the initial volume. ... as prescribers gain confidence with Vafseo, we expect adoption to accelerate, and this will trigger higher percentage rebates to dialysis organizations. To ensure predictability post-TDAPA, we expect the net net price post-TDAPA to be similar to the price of an ESA. Again, with a strong offering, we expect initial contracting to occur between now and the beginning of next year, when both Auryxia and Vafseo become eligible for TDAPA reimbursement. We're off to a great start. We're driving prescriber demand, and there's an increased interest in HIF and specifically Vafseo. We are contracting both of our products, and we have a plan to generate additional clinical data for Vafseo, which may facilitate additional clinical utilization. What's best is we still have several months to continue to execute and to amplify revenue potential upon Vafseo availability in January 2025, and we will be extremely productive during this period. Let's open the line for questions. Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. The first question will come from Allison Bratzel with Piper Sandler. Your line is now open. Hey, good morning, guys. Thanks for the update and holding the call and for taking my questions. So a couple from me. First, just on the Vafseo pricing decision, I think you mentioned that factors in the potential non-dialysis opportunity. Could you just expand on that? Any new interactions you've had with regulators that give you confidence that, you know, label expansion could be on the table, or just when we could expect an update on the path forward there? Second, just on the changes to the Vifor deal, just walk us through how this came about operationally, what this simplifies, and just, you know, if this fundamentally changes the actual economics on Vafseo sales realized by Akebia and Vifor. Then, third, just what kind of news flow or visibility do you plan to share on progress on the deal contracting strategy, you know, as we get closer to January first? Thank you. Great. Allie, thanks for joining, and thanks for the questions. So, NDD, so we're preparing to discuss NDD with the FDA this year. And, you know, we've said that before. We expect that we'll engage with them and, you know, have a path forward. You know, the great thing is, if you recall from the roxadustat and the daprodustat, AdComs, FDA agreed that this is a high unmet medical need area. Frankly, that's different than, you know, when we spoke to them five or six years ago. I think there's a real recognition that NDD patients need to be treated. And what's really interesting in the U.S. is almost 75% of patients aren't treated with ESAs today, even though they're available. So, you know, the idea of a once-a-day oral product, you know, really just makes tremendous sense. And when you look at the results of the PRO2TECT study, I mean, I know years ago, Allie, you were around then. When you look at the US data and the fact that when you treated patients to a hemoglobin of 10-11, you know, we think that really supports and particularly when you look at different GFRs, and you look at a GFR below 15, the patients who are really near dialysis, you know, they didn't have an increased MACE risk, and yet, if they're not treated before they start dialysis, they do terribly. And this is what really is driving that opportunity. So, you know, with the IRA now, you really can't change your price when you get a new indication. You have one opportunity to price your drug. So we really have to think about that expanded label as we thought about, you know, the strategic pricing. And, you know, getting outside of dialysis, where you have a more standard Part D and commercial payer mix, you know, there's an opportunity for the price to reflect the value that the product's bringing. So again, we're working on the briefing document now. Expect to have that conversation with the FDA first and then EMA after, but have that FDA feedback before the end of this year. So, and the second question was on the Vifor deal, and it was kind of operational benefits and the economics. So I'll ask Nick to comment on operational and Erik to comment on economic. Yeah, thanks for the question. You know, it really starts with Akebia now co-controls the pricing for the entire market, right? And then with that control, it simplifies decision-making around pricing and contracting. It allows complete transparency to what's going on with every single customer. And importantly, it lets us manage the ASP in a way that we hadn't had previously. You know, just to remind everybody, we've been detailing physicians all along. We've been detailing all physicians all along. Customers, though, were asking, "Why would I contract with Vifor when Akebia is in here detailing the product?" This eliminates confusion in the customer's mind. So critically important, not only operational efficiencies, but clarity for our customers on who they're working with. And that's important moving forward. Eric? Hi, and on the economics, under the new royalty-based arrangement, we expect Vafseo-related contribution to the bottom line to be modestly higher as compared to the prior arrangement, which, as you may recall, was a profit share. So I really think this just simplifies things to kind of the second element of your question. We book 100% of the revenues. There's a deduction, for the royalty. So it's, you know, again, much, much cleaner type of work. ... And, Allie, one other point on your first question that I should have mentioned, you know, why we want to engage with the FDA. Remember, in our CRL, the FDA suggested we come back and talk about patient populations where the benefit risk is positive. So, you know, they very much opened the door to this conversation as well. So, you know, we want to obviously, we want to walk through that door and make this product available because we think that opportunity is very significant and, you know, I think more than doubles the opportunity that we have in dialysis. So, your last question was around visibility that we'll provide. So, you know, this is going to be an ongoing process. We have lots of opportunities to talk to you all between now and the end of the year. Our regular earnings calls in August and November, and then, you know, September, October are very busy months for banking meetings and conferences and the like. So I think we'll have lots of opportunity, and we'll take advantage of those opportunities to keep updating you as we contract for both Auryxia and Vafseo. Very helpful. Appreciate it. Thanks, Allie. One moment for our next question. The next question comes from Ed Arce with H.C. Wainwright. Your line is open. Hi, good morning, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. So first question, in addition to the ability to control SD, as mentioned earlier, can you discuss what the major rationale for terminating the CSL agreement, especially given that about 60% of dialysis center were, including all Fresenius centers, were already locked up on the previous arrangement with CSL? Thomas, thanks so much for the question. So the market has changed a lot over the last few years. You know, we really are the only HIF activator that's being promoted in the market, and available for, well, will be available for patients. We have a commercial organization in place. We have a relationship with dialysis providers. When you think about Fresenius, we have had a relationship with Fresenius for years, and I'm going to ask Nick to make a few more comments about that because he's closer to it in the field now. But you know, we're very, very comfortable with our ability to manage this process ourselves, and this simplification is we think, very important for driving success. But Nick, maybe give a little more color there. Yeah, I mean, the Fresenius, let's kind of take that one down. They're our largest customer today, and they have a contract, an active contract with us today. They've been a wonderful partner with us on Auryxia, as demonstrated by their volume that we do with them. When I think about our engagement with them, we've already had a number of conversations around Auryxia TDAPA. This announcement today allows us to talk to them around Vafseo contract. We've had a lot of discussions with them around protocol development from our medical team. They've welcomed any insights we might have on the patient populations that need to be treated, and this allows us on the commercial front, to now engage them with Vafseo, around the contracting. In fact, we already have a meeting next week with them to talk about it. I'm very confident in our ability to work with Fresenius moving forward, as they've already demonstrated a willingness to partner with us on Auryxia and that whole plan of Vafseo as well. Yeah, I think that needs to be amplified. I mean, the ability for us now to go in and talk about contracting with Auryxia and Vafseo together, you know, that there is incredible power in that portfolio in those conversations. And, you know, now we have the ability to do that directly. Under the agreement, you know, Vifor was-- we were always responsible for the commercial execution, the sales, our reps were the ones calling on Fresenius physicians. It was just the contracting process, really, that Vifor is responsible for at Fresenius and most of the small and medium providers. And having the ability to go to all of them ourselves, with both Auryxia and Vafseo, is very, very powerful and will benefit both products. You know, we're really excited about this new arrangement. Understood. And then, perhaps on operational level, you already mentioned this, you know, a robust commercial op in place with you guys. What kind of head count increase do you anticipate that will be needed to handle the individual contracting with dialysis center? Yeah. Nick, you want to take that? Yeah, no, we, as, as we said, we have a full commercial team that's actively building, has relationships with all dialysis organizations. We, we need, if any, one, maybe zero additional headcounts for the, for the change that the Vifor agreement brings about. And so we're very confident that the people we have in place have the relationships and the ability to do this effectively. Remember, we had to have the- Got it. Auryxia contracting conversations already. You know, you don't need more people to have, to talk about two products as part of the, the, you know, your contracting. So, we'll get great leverage from this as well. ... Got it. And perhaps one last question from us. Can you discuss what is the significance of the $450 million annual sales threshold that's with the new agreement? Is this a reasonable base case peak annual sales estimate for Vafseo? Well, you know, whenever you you know have these discussions, these are negotiated numbers. So, you know, you have two different parties who have different perspectives on you know what the opportunity might be, and you work to find a place that makes sense. I mean, I think one thing that's really important to recognize, you know, Ally asked the question about NDD, and, you know, we look at NDD as a massively important opportunity. So, you know, having these tiers where if we're to get NDD approved in the U.S., and we feel, you know, highly confident in that, whether it's PRO2TECT or any other clinical work that we need to do, that will be done by Akebia. And, you know, therefore, the economic benefit from that should accrue to Akebia. I think that's sort of part of the thinking there as well. Anything to add on that, Erik? Yeah, no, I think you covered it well. Yeah. I mean, these are all, you know, parts of negotiation. Right. Thanks for your questions, Thomas. Yeah. Thank you again for taking our questions. One moment for the next question. The next question comes from Julian Harrison with BTIG. Your line is open. Hi, good morning. Thank you for taking my questions. I'm wondering if you're able to give a ballpark range of what average gross to net will look like during TDAPA in the dialysis segment. And then when non-dialysis is expected to come online, are you expecting any major differences there? So they will be very different markets, Julian. When we talk about NDD, then you're kind of more in that quote, unquote, "normal," oral product, Part D, commercial reimbursement, you know, distributed through wholesalers. I mean, it will be an easy question to give you a perspective on gross to net. I'm gonna ask Nick to go walk through the contracting and how to think about pricing. I apologize that it's a little more complicated than, you know, giving you a percentage range, but it's, you know, this is what you need to do to be successful in dialysis. So Nick, maybe you can walk through that a little bit. Yeah, absolutely. So remember, virtually 100% of the dialysis business will be contracted, and therefore, nobody will pay the WAC price. As we suggested in our script, there's a discount component which is off invoice. You'll get that from every unit, starting with unit one. The rebate piece will be dependent on your growth. If you're high growth and high volume and that dialysis organization has higher share, they'll get a deeper discount or larger rebate, which means the net price will be lower. You can imagine day one of a launch, you're not selling really much of anything, and therefore, you probably have a fairly high net price. But as people accelerate their usage and become more comfortable with the product, that usage will derive higher rebate levels, and therefore, the net price will come down over time. Now, with the mix of dialysis organizations, larges and smalls, you're gonna see different utilization across different books of business. Therefore, it's hard to pinpoint one single number, you know, but as we've reviewed the models that you guys have all put forward, you know, the average pricing in those models are, you know, let's call it between $5,000 and $8,000 per year. I think it's premature to recommend any change to those at this time. Yeah, I mean, it's just the challenge is you use one number flat and, you know, which how you like to model, but, you know, we know that this will drop. The net price per patient will drop as we increase the patient numbers. And, you know, one center might go faster than another, and so, you know, that will all be part of the net price you'll see from us. And then, and very important is that, you know, as Nick pointed out, once TDAPA is over, when we get into 2027, our pricing has to reflect much more ESA-like pricing, which is in that $2,500-$3,000 range, depending on the dose of the patients, et cetera. You know, we expect higher dose ESA patients to be ones that we get, so maybe we'll be a little bit higher. But so you'll see that price come down in 2027. Very unusual, but of course, at that point, all of the market is available to us, and we'll continue to grow and generate data. But in the near term, you have to think about off-invoice percentage rebate dropping over time as we build our share. Does that help? Yes, yes, that's very helpful. And then one more question, if I may. I'm curious if this restructuring with CSL Vifor for Vafseo, maybe makes it easier to contract with other dialysis networks beyond Fresenius. Is, is that possibly part of the plan? 100%. Nick, Nick, you want to talk about that? Yeah. I mean, again, like I suggested, we have great relationships with all dialysis organizations. You know, especially, our focus on the midsize and smaller dialysis organizations. We have a very broad reach in that customer set. They are big users of Auryxia today. And we plan on doing many direct contracts. Typically, these organizations will buy through a GPO. If that's their preference, great, but getting the opportunity to go in there and talk about TDAPA, because of any group of dialysis organizations that could be most negatively impacted by binders in the bundle, it's likely the little guys who may not have the resources to fully understand what it means or fully implement it. We can be that partner to them. We understand TDAPA. We've been in dialysis a long time, and with a portfolio of products, we can handle both their anemia management as well as their phosphate management, with them. So really look, it'll be helpful for both, both our organizations. Yeah, you know, these smaller providers are frequently the ones that can move fastest, as well. So, you know, being able to work directly with them under this new arrangement is incredibly important. I mean, frankly, when Nick's team is in talking to them about Auryxia, they ask about Vafseo, and under the other arrangement, that was Vifor's responsibility. So, you know, now we can have those direct conversations about both. Again, I don't think I can overestimate or overcommunicate the value of that portfolio approach. Okay, great. Very helpful. Congrats on the progress, and thanks again. Thanks so much, Julian. I show no further questions at this time. I would now like to turn the call back to John Butler, CEO, for closing remarks. Thanks, Michelle. You know, with our mission focused on helping patients with kidney disease, we're committing our resources to support a strong Vafseo launch to get our medication to patients. Since approval, we've seen marked progress in driving prescriber demand. Our team is in the field, and our entire organization is actively engaged in making this product a success. We're also highly engaged in contracting with dialysis organizations. The changes we've made to our relationship with Vifor enables us to be in a position to be more efficient and effective in both the contracting process and our overall approach to the market. I look forward to continuing to update you on our progress. Thanks for joining. This concludes today's conference call. Thank you for participating. You may now disconnect.