Akebia Therapeutics Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 7, 2024

There are 8 speakers on the call.

Operator

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 speakers' presentation, there will be a question and answer 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.

Operator

Please go ahead.

Speaker 1

Thank you, and welcome to Akebia's Q3 2024 Financial Results and Business Updates Conference Call. Please note that a press release was issued earlier today, Thursday, November 7, detailing our Q3 financial results, 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 today, we have John Butler, Chief Executive Officer Nick Grund, Chief Commercial Officer and Eric Ostrowski, Chief Financial and Business Officer. I'd like to remind everyone that this call includes forward looking statements.

Speaker 1

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 7 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.

Speaker 2

Thanks, Mercedes, and thanks everyone for joining us today. The Akebia team has spent the past 15 years working to bring VAPSIO 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 U. S.

Speaker 2

Market availability of VASIO vadadustat expected in January of 2025. Our team's work has yielded tremendous progress on each of our 3 launch initiatives. First, at the prescriber level, we're driving demand. 2nd, 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 VAPZIO for patients.

Speaker 2

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 VASIO. It was impossible to miss us. Here are my takeaways.

Speaker 2

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 VAPTIO is at an all time high. We presented 6 posters on VAPTIO 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 VASIO successful.

Speaker 2

Prior to ASN Kidney Week, we also shared important updates regarding reimbursement, contracting and access. In October, we secured Tdapr reimbursement from CMS and we also received Healthcare Common Procedure Coding System or HCPCS codes, which allows dialysis organizations to submit BRAVAPSIA reimbursement in January of 'twenty five. And just to remind everyone, CMS created TDAPA reimbursement system to encourage the use of innovative products for patients on dialysis. TDAPA creates positive economics for dialysis organizations that makes VAPTIO 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.

Speaker 2

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 VASIO reimbursement. This quarter, we've also made progress on our effort to secure access to VASIO 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 VASIO outcomes in center experience or VOICE trial in partnership with U.

Speaker 2

S. Renal Care, which will use 3 times per week dosing of VASIO and allow us to generate important data on key endpoints such as mortality and hospitalization that can further educate the physician community and support VASIO utilization. This study intends to enroll 2,200 patients across USRC sites and we expect the 1st patient to be enrolled in the next few weeks. Additionally, we're evaluating initiating complementary trials at other dialysis organizations. The interest among DOs is also encouraging as it suggests they're eager to understand how VAPSIO can improve care for their patients as they gain real world experience.

Speaker 2

We believe generating additional clinical data will help further our objective for VASIO 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 VAPTIO 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 And that is that 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 VASIO 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.

Speaker 2

Now let

Speaker 3

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 VASIO upon market availability. In fact, our sales team is focused nearly exclusively on VASIO.

Speaker 3

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 VASIO today 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 U. S.

Speaker 3

Renal Care, a dialysis organization serving 36,000 patients, one of the leading dialysis organizations in the U. S. 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 VASIO. 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.

Speaker 3

We previously announced the VASIO WACC 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 VASIO 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 VASIO is growing. In addition, within the contracts, GEOs are assured of predictability of price post TDAPA when we expect the price of VASIO to be essentially in line with the price of ESAs.

Speaker 3

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 1st 2 years of market availability by targeting the STAPA eligible patient population and other populations where access is enabled. While we expect a price decrease post TDAPA in 2027, again, we 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 $1,000,000,000 in just the U. S.

Speaker 3

Our intent is to enable broad access to VASIO from dialysis organizations with a 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 compelling need to have an alternative therapy available. I'll note that having the VAPSIO TIDAPA in place along with Auryxia's upcoming TIDAPA for the phosphate binder class, they're 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 include both products. We will continue to approach our commercial supply contract discussions accordingly.

Speaker 3

So contracting provides the access, reimbursement ensures the coverage, but it's the caregivers who will determine what patients are appropriate for VASIO and importantly write the prescriptions for VASIO. 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 1st 3 months of launch. With our field sales team now devoting nearly 100% of their time to VASIO, we expect these measures to continue to grow. Nephrologists are very consistent in where they expect to use the product initially.

Speaker 3

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 VASIO beyond these patient groups after gaining experience with the product and seeing the benefits of VASIO 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 DO business personnel or in broader product theater type presentation. The thoughtfulness, excitement and quality demonstrated by the Akebia team allowed for meaningful dialogue that progressed our goals.

Speaker 3

And I got to say, there is 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.

Speaker 2

Overall, we are pleased with

Speaker 3

our progress in shaping the environment for Vazio and are looking forward to putting revenue numbers on the board in quarter 1. Let me now turn it over to Eric.

Speaker 4

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 Vazio in the U. S. I'll now provide an overview of our Q3 financial results. Total revenue was $37,400,000 in the Q3 of 2024 compared to $42,000,000 in the Q3 of 2023.

Speaker 4

This consisted of $35,600,000 of Auryxia net product revenue as compared to $40,100,000 of Auryxia net product revenue during the Q3 of 2023. The decrease was primarily due to a reduction in volume, partially offset by price increases and execution of our contracting strategy with 3rd 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 Q4 of 2024 will be around the level of our net product revenue from Q2 of this year, which is lower than the Q4 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 PDAPA reimbursement for this category. More specifically, we expect distribution will largely shift away from wholesalers to dialysis organization, which will in turn decrease wholesaler inventory stocking demand.

Speaker 4

License collaboration and other revenue was steady at $1,800,000 in the Q3 of 2024 as compared to $1,900,000 in the Q3 of 2023. Cost of goods sold was $14,200,000 in the Q3 of 2024 compared to $18,000,000 in the Q3 of 2023. The decrease was driven by a $3,700,000 benefit due to our ability to commercially sell inventory previously written down as excess inventory. Research and development expense decreased to $8,500,000 in the Q3 of 2024 as compared to $13,300,000 in the Q3 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 and A expense was $26,500,000 in the Q3 of 2024, an increase from $22,700,000 in the Q3 of 2023.

Speaker 4

This increase was driven by costs incurred in connection with pre launch activities related to VASIO product availability in the U. S. And lastly, net loss was $20,000,000 in the Q3 of 2024 compared to a net loss of $14,500,000 in the Q3 of 2023. The increase in net loss included $4,400,000 in non cash interest expense related to the settlement royalty liability in connection with the D4 termination agreement. We ended the quarter with $34,000,000 in cash and cash equivalents and consistent with prior guidance have at least 2 years of cash runway.

Speaker 4

Post Q3, we raised $9,700,000 net proceeds from our ATM facility bringing pro form a end of Q3 cash to $43,700,000 With an established sales force and supply of Vapseo inventory in hand, I am pleased to say we stand well positioned from a financial point of view for VASIO U. S. Product availability in January. And with that, we welcome

Operator

Our first question comes from Allison Ratzel with Piper Sandler. Your line is open.

Speaker 5

Hey, good morning guys and thanks for taking the questions. Just a couple for me. Just on the potential for label expansion to non dialysis, 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 non dialysis approval? And then I think you covered this in the prepared remarks, but a little bit, but it seems like Akebia did have a really big presence at ASN.

Speaker 5

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.

Speaker 2

Great. Thanks, Ali. So the first question on MDD 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.

Speaker 2

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 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?

Speaker 2

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 in a reasonable amount of time that will deliver to FDA the data that they need to approve the product for non dialysis. 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 non dialysis opportunity.

Speaker 2

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. But we do expect it will be give some clarity about kind of how we'll move forward. And it's never just one interaction, right? 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.

Speaker 2

And the second question, I'll start and I'll pass it to Nick. But we had so many interactions over the course of the week. One of the things that we tried to make come through in the script was just the optimism from folks who've been working with us for years to make this product available. I mean, our roots are so deep in this community. And so many folks have worked hard to help us bring VASTO to this point.

Speaker 2

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, right? 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, investigators who came up to me at the reception that we had on the Wednesday night and when we talked about our commitment to MDD, 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, really feel strongly about the drug. I mean, all of those, I think just puts 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.

Speaker 2

But I know Nick have a lot of interactions as well. So I'll pass it

Speaker 3

to him. Yes. No, Elliot, it's great question is, my takeaways are really 3. Early in the year, while people were interested in Vazio, 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?

Speaker 3

Very specific granular questions that mean they're on the verge of implementing something within their center. 2nd, 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?

Speaker 3

Very specific that indicate a desire to write the prescription for patients in need. And lastly, many of the physicians 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 3 takeaways.

Speaker 2

Yes. 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.

Speaker 2

Does that help Ali?

Speaker 5

Yes, that helps a lot. Thanks guys.

Speaker 2

Thank you.

Operator

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

Speaker 6

Hi, guys. Good morning and 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 launch date in January and how much further you think you can get by then?

Speaker 6

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 and as you get data, how that could impact actual prescribing and administration of the drug once launched? Thank you.

Speaker 2

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.

Speaker 2

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 material that he's put together to help with enrollment. It really runs a professional organization.

Speaker 2

But so I guess as I said, we expect to see the 1st patient enrolled within the next few weeks. We hope that this is a quick enrollment. I mean, it's very broad inclusion criteria, there's 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.

Speaker 2

So with the goal as we think about study is, A, it's using 3 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.

Speaker 2

And think about it, we've got 2 years of TDAPA reimbursement. At the end of those 2 years, we have to lower the price of VASIO, 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. 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.

Speaker 2

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 3rd step is you have non dialysis approval and then when patients arrive on dialysis, they arrive on VAPSIO. 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 5 or 6 years. This is one that we expect will move quite quickly. And the dialysis contracting mix?

Speaker 3

Yes. As he said, Ed, we're at about 60% now. A goal this might sound like it's lacking humility. Our goal is to hit 100%. But it's based on really 3 important things.

Speaker 3

1, there's a reimbursement mechanism in place from CMS, TDAPA, that supports the use of innovative drugs during the 2 year period. 2nd, 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.

Speaker 3

There is a clinical need. Over 25% of patients still are not getting to GOL on today's standard of care and we believe that VASIO gives those patients an opportunity to get to goal.

Speaker 2

So 100% is absolutely our goal. Remember, there are 2 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.

Speaker 2

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.

Speaker 4

All right, great.

Speaker 6

And then just one follow-up. I noticed you made the point that right now 100 percent of the contracts that you've signed with the DOs include both Vazio 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 as what they are now as possible?

Speaker 2

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. Talk about contracting for VAPSIO because they needed to get contracts for Auryxia put in place.

Speaker 2

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 cinecalcit and Parsabiv and using those branded products for 2 years so that they have kind of there's a larger number added to the bundle at the end of that 2 year process. We do not know exactly what's going to happen with the ANDA filers for Auryxia, right? I mean there were 6 ANDA filers.

Speaker 2

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.

Speaker 2

We're very conservative as we think about 2026 and even towards the end of 'twenty five, call it the Q4 of 'twenty five. But before that, we think there's great opportunity. And the way we've built our contracts, we are able to maintain revenue even if at a lower price if we choose to. And that's important because there is power in that portfolio. And Nick, I don't know if there's anything to add there.

Speaker 3

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 needed 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.

Speaker 2

And we were there as a partner for the dialysis providers with Auryxia. Again, I mean Auryxia long term, we know that the growth of Akebia and the value we're driving is being driven by VACIO, 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 VACIO 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 needed 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 VASIO as well.

Speaker 2

So it's a very important part of our commercial thinking, but not part of our strategic growth story longer term.

Speaker 6

Got it. Thanks so much.

Speaker 2

Thanks, Ed.

Operator

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

Speaker 7

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 BAPCO. 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?

Speaker 7

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 the clinic for those efforts? If you could talk about the remaining steps of first INDs, that'd be helpful as well.

Speaker 3

Nick, the home

Speaker 4

question?

Speaker 3

Yes. 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 homePD population and the high dose ESA.

Speaker 3

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.

Speaker 2

Thanks for that. So, Julian, thanks so much for the question on our early programs. I know that everyone's focus is on a VASIO 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.

Speaker 2

And so AKB-nine thousand and ninety, which is the AKI program that you referenced, we're in kind of pre IND development now doing tox work, etcetera. 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.

Speaker 2

And then of course, 1010 8, our program in retinopathy of prematurity, which I'm equally if not more excited about is behind 9,090. But we're moving that product forward, doing CMC work, etcetera. We had an advisory board meeting on 10108 on retinopathy of prematurity 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.

Speaker 2

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 appreciate that question.

Operator

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

Speaker 2

Thanks, operator. In summary, our contracting is going extremely well and we're very well positioned for a running start when VAPSIO is available in January. The near and long term commercial success of Vapseo hinges on our ability to execute on these initiatives we discussed today. 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.

Speaker 2

We look forward to updating you on our progress then. Thanks everyone. Have a great day.

Operator

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

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Key Takeaways

  • Akebia expects U.S. market availability of VAPZIO (vadadustat) in January 2025, backed by strong momentum across prescriber engagement, dialysis organization contracting, and clinical initiatives.
  • They secured TDAPA reimbursement and HCPCS codes from CMS, creating favorable economics for dialysis organizations during the two-year TDAPA period and ensuring efficient VAPZIO reimbursement.
  • Commercial supply contracts with major providers like U.S. Renal Care, DaVita, and Renal Purchasing Group already cover about 60% of U.S. dialysis patients, with a goal of nearly 100% coverage by the end of the year.
  • They initiated the VOICE outcomes trial with U.S. Renal Care to enroll 2,200 patients on thrice-weekly dosing, aiming to generate real-world data on mortality and hospitalization to support broader adoption post-TDAPA.
  • Akebia plans to engage with the FDA by year-end on a label expansion into the non-dialysis CKD population, aiming to define a clinical path for broader approval beyond dialysis patients.
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Earnings Conference Call
Akebia Therapeutics Q3 2024
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