Akebia Therapeutics, Inc. Q3 FY2024 Earnings Call

Good day and thank you for standing by. Welcome to 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. 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 as 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 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 caregivers and investigators, representatives from dialysis organizations, and patient advocacy groups. Akebia is committed to the kidney community, and we believe we have widespread support to make Vafseo successful. Prior to ASN Kidney Week, we also shared important updates regarding reimbursement contracting and access. In October we secured TDAPA reimbursement from CMS and we also received Healthcare Common Procedure Coding System or HCPCS codes, which allows dialysis organizations to submit for Vafseo reimbursement in January of 2025. And just to remind everyone, CMS created the TDAPA reimbursement system to encourage the use of innovative products for patients on dialysis. TDAPA creates positive economics for dialysis organizations that makes Vafseo a desirable addition to their formularies. While receiving TDAPA reimbursement payment was our expectation, we're pleased to have the assurance provided by this program as we engage in further contracting discussions. Now that we have the HCPCS codes, our key account managers can begin to educate dialysis organizations to ensure that these codes are known at each site to facilitate efficient Vafseo reimbursement. This quarter, we've also made progress on our effort to secure access to Vafseo through commercial supply contracts with dialysis providers and group purchasing organizations. Nick will provide more details and speak to our goal of securing coverage for nearly 100% of patients on dialysis by the end of the year. Finally, we're progressing on plans to generate new clinical data. In September, we initiated our Vafseo Outcomes In-Center Experience or VOICE trial, in partnership with US Renal Care, which will use three times per week dosing of Vafseo and allow us to generate important data on key endpoints such as mortality and hospitalization that can further educate the physician community and support Vafseo utilization. This study intends to enroll 2,200 patients across USRC sites, and we expect the first patient to be enrolled in the next few weeks. Additionally, we're evaluating initiating complementary trials at other dialysis organizations. The interest among dialysis organizations is also encouraging, as it suggests they're eager to understand how Vafseo can improve care for their patients as they gain real-world experience. We believe generating additional clinical data will help further our objective for Vafseo to become the new oral standard of care for the treatment of anemia due to chronic kidney disease. We look forward to working closely with USRC and other dialysis organizations to advance our understanding of additional potential benefits Vafseo treatment can bring to dialysis patients. Now, one final thought I'll share regarding ASN Kidney Week, based on conversations we continue to have with nephrologists. The unmet need for anemia treatment for patients with CKD who are not on dialysis is more significant than ever and represents an additional multibillion-dollar opportunity beyond the dialysis population. That is a resounding message from physicians, and at ASN, we reiterated our commitment to exploring a path for Vafseo label expansion into the non-dialysis CKD patient population. As we've said previously, we expect to provide a more detailed update on this initiative by the end of the year. Now, let me turn it over to Nick to talk more about our commercial activities.

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 through our HCP education and patient identification efforts. We are also hard at work to complete commercial supply contracts, facilitate processes at the 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 dialysis organizations and group purchasing organizations, 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 is growing. In addition, within the contracts, dialysis organizations are assured of predictability of price post-TDAPA when we expect the price of Vafseo to be essentially in line with the price of ESAs. This pricing strategy and our commitment to access, we believe will enable Akebia to have a strong launch. We expect to generate revenue within the first two years of market availability by targeting the TDAPA-eligible patient population and other populations where access is enabled. While we expect a price decrease post-TDAPA in 2027, we again expect it will be offset by a potential volume increase, as we will then be targeting the entire dialysis patient population, not just those who were previously eligible for TDAPA. The anemia management market in dialysis alone today is approximately $1 billion in just the U.S. Our intent is to enable broad access to Vafseo from dialysis organizations with the goal of having agreements in place with dialysis organizations covering nearly 100% of dialysis patients. We continue to work on additional commercial supply contracts, and with over 25% of patients not getting to goal, we believe there is a compelling need to have an alternative therapy available. I'll note that having the Vafseo TDAPA in place along with AURYXIA's upcoming TDAPA for the phosphate binder class, they are both additional levers that we can pull as we pursue additional commercial supply contracts. Dialysis organizations are preparing for this distribution change, and as such there are advantages of contracting across the Akebia portfolio of products, as demonstrated by 100% of our contracts to-date including both products. We will continue to approach our commercial supply contract discussions accordingly. So contracting provides the access, and reimbursement ensures the coverage, but it's the caregivers who will determine what patients are appropriate for Vafseo, and importantly, write the prescriptions for Vafseo. To that end, our team has also been making good progress connecting with prescribers to drive awareness and demand. As a result, we have seen significant increases in awareness and importantly, 92% of physicians surveyed intended to use the product, with a robust 27% of physicians intending to use the product within the first three months of launch. With our field sales team now devoting nearly 100% of their time to Vafseo, we expect these measures to continue to grow. Nephrologists are very consistent in where they expect to use the product initially. The focus is on home patients as well as patients on the highest doses of ESAs. These are segments where physicians attribute the greatest unmet need and they total more than 200,000 patients. We believe prescribers will expand utilization of Vafseo beyond these patient groups after gaining experience with the product and seeing the benefits of Vafseo for these initial patients. The only additional insight to John's comments on ASN is regarding the high level of engagement, whether it was in the booth, in meetings with medical experts and dialysis organization business personnel, or in broader product theater type presentations. The thoughtfulness, excitement, and quality demonstrated by the Akebia team allowed for meaningful dialogue that progressed our goals. And I got to say, there's nothing more reassuring to a commercial person than walking into a trade show and seeing attendees a couple deep waiting to engage with our people and our content. Overall, we are pleased with our progress in shaping the environment for Vafseo and are looking forward to putting revenue numbers on the board in quarter one. Let me now turn it over to Erik.

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 the 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 inventory. Research and development expense decreased to $8.5 million in the third quarter of 2024, as compared to $13.3 million in the third quarter of 2023, which was driven by the completion of activities related to certain clinical trials, lower headcount-related costs, and decreased professional service and consulting expense. SG&A expense was $26.5 million in the third quarter of 2024, an increase from $22.7 million in the third quarter of 2023. This increase was driven by costs incurred in connection with prelaunch activities related to Vafseo product availability in the US. And lastly, net loss was $20 million in the third quarter of 2024, compared to a net loss of $14.5 million in the third quarter of 2023. The increase in net loss included $4.4 million in noncash interest expense related to the settlement royalty liability in connection with the Vifor termination agreement. We ended the quarter with $34 million in cash and cash equivalents and consistent with prior guidance, we have at least two years of cash runway. Post Q3, we raised $9.7 million in net proceeds from our ATM facility, bringing pro forma end of Q3 cash to $43.7 million. With an established sales force and supply of Vafseo inventory in hand, I am pleased to say we stand well positioned from a financial point of view for Vafseo US product availability in January. And with that, we welcome questions.

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. As we've said, we expect to engage with the FDA this year. It's kind of hard to say what the outcome will be of that until we have the engagement. 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. 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, and 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. Everything will always be a review issue. But you want to know that you have alignment that you're delivering a protocol and a study that they will view positively, and that's our hope. 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 the FDA the data they need to approve the product for nondialysis. Again, 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 the FDA as well. But it will be a little bit of when we get the feedback, we'll know exactly what we'll be able to share with you. We do expect it will give some clarity about how we'll move forward. It's never just one interaction; that first interaction gives you a path and then you continue to interact with them to make sure you're delivering them what they need to facilitate the approval. The second question, I'll start, and I'll pass it to Nick. We had so many interactions over the course of the week. One of the things that we tried to convey in the script was just the optimism from folks who've been working with us for years to make this product available. Our roots are so deep in this community. So many folks have worked hard to help us bring Vafseo to this point. I think everyone was excited for us and for themselves that they have this opportunity to make the product available. For sure that doesn't mean no one's written a prescription yet. I mean, we still have to execute absolutely. But I think it starts with that level of positivity, whether it was the KMEs who've been part of our steering committee or the patient groups that I referenced, and investigators who came up to me at the reception that we had on the Wednesday night. When we talked about our commitment to NDD, they came up and talked about wanting to be part of that study, because they've been part of studies we've done in the past and really feel strongly about the drug. All of those factors put us in a really positive spot and a really differentiated spot versus other HIF products that have launched without that kind of commitment and excitement. But I know Nick had a lot of interactions as well, so I'll pass it to him.

Yeah. No, Ali, it's a great question. 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, as John mentioned 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. 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 realizing the shortcomings of their current ESA therapies. 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 we've all been associated with nephrology launches before. They will name numbers, but it still takes them a long time to do things. 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. 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 timeline of that trial. 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. We've worked with Jeff for over 20 years. He's an amazing trialist. He gets studies enrolled incredibly efficiently, and I couldn't be happier that he was very excited about working on this trial with us. We expect to see the first patient enrolled within the next few weeks. We hope that this is a quick enrollment. I mean, it has very broad inclusion criteria, with 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 every patient in the study will have at least a set amount of follow-up. The goal of the study is to generate data that we believe will show a benefit. Getting data from VOICE will be significant. 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. The entire dialysis population will be available to us. The way we think about it is physicians gain experience using it in those patients where there is a TDAPA benefit and they see how well it works for patients. That will allow for standard care penetration quite significantly. Then the third step is you have non-dialysis approval, making sure that when patients arrive on dialysis, they arrive on Vafseo. So getting data from VOICE as soon as possible after the TDAPA period ends will be important. But this isn't a study that's supposed to last five or six years; we expect it to move quickly. Now the dialysis contracting mix.

Yes. As you mentioned, Ed, we are currently around 60%. Our goal is to reach 100%. This aim is supported by three key factors. First, there is a reimbursement mechanism in place from CMS TDAPA that facilitates the use of innovative drugs during the two-year period. Second, our pricing strategy offers favorable economics for dialysis organizations during the TDAPA phase related to our product. Importantly, we have established predictability post-TDAPA with pricing that closely resembles ESA pricing. Lastly, these factors are only significant if there is a clinical need, which indeed exists. Over 25% of patients are still failing to reach their goals with the current standard of care, and we believe Vafseo provides those patients with a chance to meet their objectives. Therefore, achieving 100% is certainly our aim.

Remember, there are two providers, one of whom we have under contract already, representing about 70%. So you know where a lot of our efforts are focused. One quick follow-up to clarify on the VOICE study: we know that the FOCUS study, which we've long expected to be published, is expected to go online any day now. We think that work is sufficient to go to the FDA and have the TIW dosing added to our label. We've made the strategic decision to focus on nondialysis patients first and then we will address TIW after we have the FOCUS publication and dialysis providers will start getting that experience. We don't think we need the VOICE study for FDA approval, but we view it 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 dialysis organizations 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. Auryxia has been such an important part of the past year for us. Dialysis providers have allowed us to talk about contracting with Vafseo because they needed to put contracts for Auryxia in place. This has enabled a lot of these contracting discussions. We have those Auryxia contracts in place. We know providers are looking at that addition of the binders to the bundle and thinking about that process that happened with cinacalcet and Parsabiv, using those branded products for two years to have 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. There are six ANDA filers, but no ANDAs have been conditionally approved at this point. We don't know who will introduce products at the end of March, if anyone of course, we have to wait and see. You have your first filer being generally an authorized generic, so there will be limited competition for most of 2025. That allows us to maintain stronger access for Auryxia on a branded basis. All those pieces put together for 2025, we're conservative as we think about 2026 and towards the end of 2025, call it the fourth quarter of 2025. Before that, we think there's great opportunity. 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 important, because there is power in that portfolio. And Nick, I don't know if there's anything else to add there.

No, I think you had it all. It's the predictability that being with the branded manufacturer allows us, and the opportunity to reduce our price if necessary due to generic competition. It gives dialysis organizations peace of mind that we have the ability to be there throughout the generic process.

We're there as a partner for the dialysis providers with Auryxia. Auryxia long-term, we know that the growth of Akebia and the value we're driving is driven by Vafseo long term. I think of Auryxia as a tool to enable that Vafseo growth. It's something that's a great product, a product they want on formulary. They want to be able to use it. They need to have contracts in place, and we're there to support them through that. We believe that will help them to decide to incorporate Vafseo as well. 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.

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?

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 two populations that come to mind when we talk to physicians are certainly the home/PD population and the high-dose ESA population. 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 the Vafseo launch, and it's our focus as well. But we are really excited about our early-stage programs, and we think a lot about the future growth of the company and what will fuel our growth in the future. AKB-9090, which is the AKI program that you referenced, we are in pre-IND development now, doing tox work, etc. 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 hold on tight, but we're quite excited about that. 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, etc. We had an advisory board meeting on 10108 on retinopathy of prematurity a couple of months ago, 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.