Good day and thank you for standing by. Welcome to the Akebia's Third Quarter 2024 Financial Results 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. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.

Thank you and welcome to Akebia's third quarter 2024 financial results and business update conference call. Please note that a press release was issued earlier today, Thursday, November 7th, detailing our third quarter 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 November 7th 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 CEO John Butler.

Thanks, Mercedes and thanks everyone for joining us today. The Akebia team has spent the past 15 years working to bring Vafseo to patients. So I have to say, I get excited every time I have the opportunity to give an update on the progress we're making in the home stretch of that journey. We're building significant momentum as we prepare for US market availability of Vafseo, vadadustat expected in January of 2025. Our team's work has yielded tremendous progress on each of our three launch initiatives. First at the prescriber level, we're driving demand. Second, we're focused on contracting effectively with dialysis organizations to have meaningful -- and have meaningful progress to share. And third, we've launched clinical initiatives to generate data that could demonstrate potential additional benefits of Vafseo for patients. I recently returned from the American Society of Nephrology or ASN Kidney Week. As I mentioned previously, I considered this our coming out party. Team Akebia had a formidable presence focused on engagement across the kidney community, building awareness and advocacy for Vafseo. It was impossible to miss us. Here are my takeaways. Over and over again, I heard from nephrologists that they're ready for a new choice in anemia management for their dialysis patients and they want to ensure their patients have access. Considering the traffic to our medical affairs booth, the interest in reviewing our existing clinical data and analyses on Vafseo is at an all-time high. We presented six posters on Vafseo data and our authors and partners spent their time delving into the findings and responding to physician questions. Now I'll let Nick share more detail on prescriber demand and commercial efforts. But overall I'm extremely encouraged by the optimism that I felt amongst our team and within the broader kidney community from…

Thanks, John. Good morning, folks. We continue to execute on our market readiness plans to foster and enable a strong market reception for Vafseo upon market availability. In fact, our sales team is focused nearly exclusively on Vafseo. Awareness and more importantly demand is building, building through our HCP education and patient identification efforts. We are also hard at work to complete commercial supply contracts, facilitate processes at dialysis center business level and set up our distribution network. The significant commercial contracts that we have established for Vafseo to date, along with the TDAPA and HCPCS codes we recently received, we believe will enable us to drive uptake within a significant percentage of the dialysis market immediately, upon launch. To recap, our current commercial supply contracts include engagements with US Renal Care, a dialysis organization serving 36,000 patients, one of the leading dialysis organizations in the US, serving more than 200,000 patients and thousands of dialysis centers and most recently an engagement with Renal Purchasing Group, a specialty group purchasing organization that serves many of the independent and small dialysis organizations. Through our contracts with DOs and GPOs, approximately 60% of patients on dialysis have access to Vafseo. The dialysis organizations and group purchasing organizations have been active participants, in the contracting process, and it's clear that leaders within the organizations share our commitment to delivering innovative treatments to people living with kidney disease. We previously announced the Vafseo WAC of approximately $15,500 per year. Our commercial supply contracts are coming together as we expected, and include an off-invoice discount and volume-based rebates. Through the volume-based rebates as Vafseo use increases, the price will decline. From an Akebia perspective, this is a dynamic we welcome, as it implies that if the price decreases the utilization and market share of Vafseo…

Thanks Nick. As John and Nick have expressed, the team has been working incredibly diligently across a number of initiatives and excitement is building both internally and externally for availability of Vafseo in the U.S. I'll now provide an overview of our third quarter financial results. Total revenue was $37.4 million in the third quarter of 2024, compared to $42 million in the third quarter of 2023. This consisted of $35.6 million of AURYXIA net product revenue as compared to $40.1 million of AURYXIA net product revenue during the third quarter of 2023. The decrease was primarily due to a reduction in volume partially offset by price increases and execution of our contracting strategy with third-party payers. Looking forward, despite the fact that we believe overall market demand for AURYXIA and other phosphate binders has been steady throughout this year we expect AURYXIA net product revenue in the fourth quarter of 2024 will be around the level of our net product revenue from Q2 of this year, which is lower than the fourth quarter of 2023. This is being driven by the anticipated disruption to the supply chain for the broad phosphate binder class in late 2024 ahead of 2025 TDAPA reimbursement for this category. More specifically, we expect distribution will largely shift away from wholesalers to dialysis organizations, which will in turn decrease wholesaler inventory stocking demand. License collaboration and other revenue was steady at $1.8 million in the third quarter of 2024, as compared to $1.9 million in the third quarter of 2023. Cost of goods sold was $14.2 million in the third quarter of 2024, compared to $18 million in the third quarter of 2023. The decrease was driven by a $3.7 million benefit due to our ability to commercially sell inventory previously written down as excess…

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

Hey good morning guys and thanks for taking the question. Just a couple for me. Just on the potential for label expansion to nondialysis, could you sort of frame kind of what kind of update on the regulatory interactions we can be expecting? And just kind of what are the potential range of outcomes from those regulatory interactions in terms of defining a path to nondialysis approval? And then I think you covered this in the prepared remarks a little bit, but it seems like Akebia did have a really big presence at ASN. Just hoping you could characterize the kind of feedback you've been getting from docs on that. Are there any themes that stand out that you'd like to call out? Thank you.

Great. Thanks Ali. So, the first question on NDD label expansion. So, as we've said, we expect to engage with FDA this year. It's kind of hard to say what the outcome will be of that until we have the engagement. And so -- but our expectation is and what we want is we know we have to do clinical work to get an NDD label. That was clear in the CRL. As we've said before, they were open to and said in the CRL, come back and discuss your patient group that makes sense for where the benefit risk is positive, right? So we believe we've outlined that and are looking to engage with them on that conversation and on what a protocol would look like, what a study would look like to get there. You know as well as I, it's not like the FDA is going to say, yes that's great. Do that and you'll get approved, right? I mean everything will always be a review issue. But you want to know that you have alignment that you're delivering a protocol a study that they will view positively. And that's our hope. And that's what we hope to be able to describe to folks that we have a clinical path that makes sense for us that we can do for a reasonable amount of money and a reasonable amount of time that will deliver to FDA the data that they need to approve the product for nondialysis. Again, I mean they recognize that there is a high unmet need. I mean sort of leaking into your second question, every patient group that I spoke to at ASN and we spoke to them all individually, they talked about the nondialysis opportunity. So, I'd expect them to engage with…

Yeah. No Ali, it's a great question is my takeaways are really three. Early in the year, while people were interested in Vafseo, the urgency was much less than you see now. Now, it's up "when can I get it? Is it contracted? Do I have access? What does the distribution look like?" Very specific granular questions that mean they're on the verge of implementing something within their center. Second John mentioned it in his prepared remarks the level of clinical questions we're getting now aren't so much of "Hey who do you think I should use it in?" It's "What's the dose? How do I start them? When do I stop the prior therapy?" Very specific to indicate a desire to write the prescription for patients in need. And lastly, many of the physicians that I talked to were really highlighting the need for an alternative therapy. They look at us as potentially a standard of care but they're also second to that realizing the shortcomings of their current ESA therapies. And so that need is really brought forward in that not only is there a patient need there's also a product need. So those are my three takeaways.

Honestly, I mean sometimes you have physicians, who are naming numbers, right? I mean, and it's -- we've all been associated with nephrology launches before, right? I mean, they will name numbers but it still takes them a long time to do things. And we -- that's why it's been so nice to have this time pre-product availability to kind of wade through some of that inactivity and get to the place where Nick just described. Does that help Ali?

Yes. That's helps a lot. Thanks, guys.

Thank you.

Thank you. Our next question comes from Ed Arce with H.C. Wainwright. Your line is open.

Hi, guys. Good morning. Congrats on all the good work at San Diego recently. A couple of questions for me and then maybe a follow-up. Firstly, you mentioned on your release that you're now at approximately 60% of the dialysis centers with supply contracts. I'm wondering, if you had a certain goal in mind by the launch date in January? And how much further you think you can get by then? And then secondly, around the VOICE trial, I know, you said, you're looking to start enrollment here in a few weeks. Wondering, if you could discuss sort of the time line of that trial. And as you get data how that could impact actual prescribing and administration of the drug once launched. Thank you.

Thanks, Ed. So I'm going to do the second one first and then I'm going to hand it to Nick to talk about the dialysis center. So the VOICE trial again, which is a collaborative research study with U.S. Renal Care and Jeff Block is the lead investigator on that. And we've worked with Jeff -- I've worked with Jeff for 20-something years. He's an amazing trialist. He gets studies enrolled incredibly efficiently and I couldn't be happier that he was very, very excited about working on this trial with us. I've seen some of the materials he's put together to help with enrollment. He really runs a professional organization. But -- so I guess as I said we expect to see the first patient enrolled within the next few weeks. We hope that this is a quick enrollment. I mean it's very broad inclusion criteria, patients on dialysis very few exclusions for that. The goal is -- we haven't talked about when we expect it to be fully enrolled or completed, but it is an outcome study, right? So there's an amount of follow-up after the last patient enrolls that everyone -- every patient in the study will have at least a set amount of follow-up. So -- but the goal as we think about the study is a it's using three times weekly dosing, right? So that gives USRC a significant amount of experience using that dosing regimen makes the investigators comfortable with that. And we think that will impact how they think about protocols at USRC -- and probably beyond USRC when others see that this very significant dialysis provider is using that dosing regimen successfully. So we think that will have a very important near-term impact. But the reason that we're doing the study is to generate this data that we believe will show a benefit. And think about it we've got two years of TDAPA reimbursement. At the end of those two years, we have to lower the price of Vafseo. But now we get to fish in the entire pond if you will right? I mean the entire dialysis population will be available to us. We -- the way we think about it is physicians get experience using it in those patients where there's a TDAPA benefit. They like the product. They see how well it works for patients. Then you generate additional positive data and that allows that next step of becoming standard of care really penetrating that market quite significantly. Then the third step is you have non-dialysis approval. And then when patients arrive on dialysis they arrive on Vafseo. So getting data from VOICE as soon as possible after the TDAPA period ends or before -- again it really depends on how quickly we enroll. But this isn't a study that's supposed to last five or six years. This is one that we expect will move quite quickly. And the dialysis contracting mix.

Yes. As you said Ed, we're at about 60% now. A goal -- this might sound like it's lacking humility. Our goal is to hit 100%. And it's based on really three important things. One, there's a reimbursement mechanism in place from CMS TDAPA that supports the use of innovative drugs during the two-year period. Second, our pricing strategy. We've created a pricing strategy that should allow for the DOs to have good economics during the TDAPA period around our product. And importantly we've created predictability post TDAPA through matching or being very similar to ESA pricing. And then lastly, none of those things really matter unless there's a clinical need. There is a clinical need. Over 25% of patients still are not getting to goal on today's "standard of care" and we believe that Vafseo gives those patients an opportunity to get to goal.

So 100% is absolutely our goal. Remember there are two providers one of whom we have under contract already who represent about 70%. So you know where a lot of our efforts are focused. And just one quick follow-up to clarify on the VOICE study. We have -- recall we have the FOCUS study which we expect to be published any day. It's been accepted for publication. We expect it to be online any day now. We think that that work is sufficient to go to the FDA and have the TIW dosing added to our label. Recall we've made the strategic decision to focus on NDD first and then go do -- talk to them about TIW after as we will have the FOCUS publication and dialysis providers will be getting that experience. But we don't think we need the VOICE study for FDA approval. We really think about that as a way to generate more data to help expand access to the product post TDAPA.

All right. Great. And then just one follow-up. I noticed you made the point that right now 100% of the contracts that you've signed with the DOs include both Vafseo and Auryxia, and as we look to generics of Auryxia coming in pretty soon, I'm wondering if you can discuss the efforts you've mentioned previously around maintaining those revenue levels as close to what they are now as possible.

Yes. It's -- Auryxia has been such an important part of the past year for us. Nick kind of referenced it. Dialysis providers allowed us in to talk about contracting with Vafseo, because they needed to get contracts for Auryxia put in place. And it really has enabled a lot of these contracting discussions and has been incredibly important for us. We are -- again, we have those Auryxia contracts in place. We know that providers are looking at that addition of the binders to the bundle and thinking about that process that happened with cinacalcet and Parsabiv and using those branded products for two years so that they have kind of -- there's a larger number added to the bundle at the end of that two-year process. We do not know exactly what's going to happen with the ANDA filers for Auryxia, right? I mean there were six ANDA filers. There's no ANDAs that have been conditionally approved at this point in time. So, we don't know who's going to introduce products at the end of March, if anyone of course. You've got your first filer generally an authorized generic. So it will be limited competition for most of 2025. I think that allows us to maintain stronger access for Auryxia on a branded basis. All of those pieces put together for 2025. We're very conservative as we think about 2026 and even towards the end of 2025, call it the fourth quarter of 2025. But before that, we think there's great opportunity. And the way we've built our contracts, we're able to maintain revenue even if at a lower price if we choose to. And that is -- that's important, because there is power in that portfolio. And Nick, I don't know if there's anything to add there.

No, I think you had it all. I mean, again, it's the predictability that being with the branded manufacturer that we can provide and having that opportunity to reduce our price if need to be due to generic competition. It allows them not to have to spend the operational cost to switch and enter a generic formulation into their protocol and generics come and go into the marketplace over time. I think it provides the DOs with a bit of peace of mind that we have the ability to be there throughout the generic process if you will.

We're there as a partner for the dialysis providers with Auryxia. Again, I mean, Auryxia’s long-term, we know that the growth of Akebia and the value we're driving is being driven by Vafseo right long-term. I mean this is -- I hate to say it this way, but I think of Auryxia as a tool to enable that Vafseo growth, right? I mean, it is something -- it's a great product, a product they want on formulary. They want to be able to use. They need it to have contracts in place, and we're there to support them through that. And we believe that will help them to make the decision to incorporate Vafseo as well. So, it's a very important part of our commercial thinking but not part of our strategic growth story longer term.

Got it. Thanks so much.

Thanks Ed.

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

Hi. Good morning. Congrats on all the momentum, and thank you for taking my questions. It's great to see the progress on the contracting front for Vafseo. I'm wondering if you're able to share approximately what percent of the home dialysis segment is contracted at this time. Is it approximately 60% higher or lower than that? And then also for your earlier-stage programs like acute kidney injury, are you giving any guidance now for how soon you plan to be in the clinic for those efforts? If you could talk about the remaining steps of first INDs, that would be helpful as well.

Nick, the home?

Yeah. And so while the percent home in each dialysis organization changes a little bit, both the home as well as the in-center population are included in all of our contracts. So none of our contracts excluded. Ultimately, it will come down to, as we suggested, writing the protocols. But the 2 populations that come to mind when we talk to physicians is certainly the home/PD population. and the high-dose ESA. And so in reality, there's probably very little difference between the percentage, 60% approximately that we have on the overall and how that splits up between home and in-center.

Thanks for that. So Julien, thanks so much for the question on our early programs. I know that everyone's focus is on Vafseo launch, and it's our focus as well, right? We know we need to do that incredibly well. But at the same time, we're really excited about our early-stage programs, and we really think a lot about kind of the future growth of the company and what will fuel our growth in the future. And so AKB-9090, which is the AKI program that you referenced, we're in kind of pre-IND development now, doing tox work, et cetera. And our goal is to have it in the clinic before the end of next year. as we've said before. We seem to be on track for that. It's an early-stage program. So you always have to kind of hold on tight, but we're quite excited about that. And then, of course, 10108, our program in retinopathy of prematurity, which I'm equally, if not more excited about, is behind 9090, but we're moving that product forward, doing CMC work, et cetera. We had an advisory board meeting on 10108 on retinopathy of prematurity a couple of months ago, I guess, now. And I remember texting Steve Burke, our CMO, during the meeting, just talking about how we have to move faster. These folks were just so excited about the opportunity that product could have in that population of neonates. So we're really excited about moving that one forward. But that one clearly is not going to be in the clinic next year, but hopefully, as soon after 9090 as we can move it. But I appreciate that question.

Thank you. This concludes the question-and-answer session. I would now like to turn it back to John Butler, CEO, for closing remarks.

Thanks, operator. In summary, our contracting is going extremely well, and we're very well positioned for a running start when Vafseo is available in January. The near- and long-term commercial success of Vafseo hinges on our ability to execute on these initiatives we discussed today. But I'm pleased to say we've been hitting on every internal metric. We look forward to seeing many of you during our investor meetings later this year and then in San Francisco in January. We look forward to updating you on our progress then. Thanks everyone. Have a great day.

This concludes today's conference call. Thank you for participating. You may now disconnect.