Akebia Therapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Akibia'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. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. 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 TVA's third quarter 2024 financial results and business updates 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 investor 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 Grundt, Chief Commercial Officer, and Eric 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. You know, the Akiba team has spent the past 15 years working to bring Vapcio 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. market availability of Vapcio, Vatadustat, expected in January of 25. 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 Vafsio 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 Akibia had a formidable presence, focused on engagement across the kidney community, building awareness and advocacy for Vafsio. 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 Vafsio is at an all-time high. We presented six posters on Vafsio 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. Akibia is committed to the kidney community, and we believe we have widespread support to make Vafcio successful. Now, 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 VAPCIA reimbursement in January of 25. 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 VAPCO 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 Vafsio reimbursement. This quarter we've also made progress on our effort to secure access to Vafsio 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.S. Renal Care, which will use three 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 first 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 Vafsio can improve care for their patients as they gain real-world experience. We believe generating additional clinical data will help further our objective for Vafsio 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 VAPCO 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 multi-billion 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 Vafcio 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 VASIO upon market availability. In fact, our sales team is focused nearly exclusively on VASIO. 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 VASU 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 U.S. 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. We previously announced the Vasio 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 VASIO use increases, the price will decline. From an Akibia 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, DOs are assured of predictability of price post-TDAPA when we expect the price of VASIO to be essentially in line with the price of VSAs. This pricing strategy and our commitment to access, we believe, will enable Akibia 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, 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 billion in just the US. 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 a compelling need to have an alternative therapy available. I'll note that having the Vapcio Tdapa in place along with Oryxia's upcoming Tdapa 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 Akiba 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. 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 first three 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. 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 Akiva team allowed for meaningful dialogue that progressed our goals. And I've 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 VASIO and are looking forward to putting revenue numbers on the board in quarter one. Let me now turn it over to Erica.

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 DAFTO in the US. 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 orexia net product revenue as compared to $40.1 million of orexia 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 orexia and other phosphate binders has been steady throughout this year, we expect orexia 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 to adapt a 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. 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. 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 VAPCO product availability in the U.S. 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 non-cash interest expense related to the settlement royalty liability in connection with the D4 termination. We ended the quarter with $34 million in cash and cash equivalents, and consistent with prior guidance, have at least two years of cash runaway. 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 Vastio inventory in hand, I am pleased to say we stand well positioned from a financial point of view for Bastio US product availability in January. And with that, we welcome questions.

As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Our first question comes from

Allison Bratzel with Piper Sandler. Your line is open.

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, you know, we can be expecting from 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 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, you know, as we've said, we expect to engage with FDA this year. You know, it's kind of hard to say what the outcome will be of that until we have the engagement. And, you know, so, but our expectation is, and what we want, is we know we have to do clinical work to get an NDD label. That's You know, that was clear in the CRL. You know, as we've said before, they were open to, you know, and said in the CRL, come back and discuss your patient group that makes sense for where the benefit-risk is positive, right? So, you know, 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, And, you know, it's not like the FDA is going to say. Yeah, that's great. Do that and you'll get approved right in the middle. Everything will always be a review issue, but you want to know that you have alignment that you're delivering a protocol study that they will view positively. And that's that's our hope. And that's what we hope to be able to. to describe to folks that, you know, we have a clinical path that makes sense for us that we can do, you know, 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 non-dialysis. Again, I mean, they recognize that there's a high-end met need. I mean, sort of leaking into your second question, you know, every patient group that I spoke to at ASN, and we spoke to them all individually, you know, they talked about the non-dialysis opportunity. So, you know, I'd expect them to engage with the FDA as well. But it will be a little bit of, you know, 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, you know, 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. And the second question, I'll start and I'll pass it to Nick. But, you know, 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. Our roots are so deep in this community, and so many folks have worked hard to help us bring Vapstio to this point. I think everyone was excited for us and for themselves that they have this opportunity you know, to make the product available. For sure, that doesn't mean, you know, no one's written a prescription yet, right? I mean, we still have to execute. Absolutely. But, you know, 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, you know, came up to me at the reception that we had, you know, on the Wednesday night and you know, 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, you know, 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, you know, 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, it's great question is, you know, my takeaways are really three. Early in the year, while people were interested in VASIO, the urgency was much less than you see now. Now it's a, 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 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 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 three takeaways.

Yeah, honestly, I mean, sometimes you have physicians who are naming numbers, right? I mean, it's, you know, 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 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, Allie?

Yeah, that helps a lot. Thanks, guys.

Thank you.

Thank you. Our next question comes from Ed Arcee with HC Wainwright. Your line is open.

Hi, guys. Good morning. And congrats on all the good work at San Diego recently. A couple 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. 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.

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 us, 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 trial list. 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. It really runs a professional organization. But so, you know, 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. You know, it's patients on dialysis, very few exclusions for that. You know, the goal is, you know, we haven't talked about when we expect it to be, you know, fully enrolled or completed, but it is an outcome study, right? So, you know, there's an amount of follow-up after the last patient enrolls that everyone, every patient in the study will have at least, you know, a set amount of follow-up. But the goal as we think about study is, you know, A, it's using three times weekly dosing, right? So, you know, that gives USRC a significant amount of experience using that dosing regimen, makes the investigators comfortable with that. And, you know, we think that will impact how they think about protocols at USRC and probably beyond USRC when others, you know, see that this very significant dialysis provider is 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 Vafcio, 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 Tdap of 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, 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 Vafsio. 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, you know, five or six years. This is one that we expect will move quite quickly. And the dialysis contracting next.

Yeah, as you said, Edward, 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 quote-unquote standard of care, and we believe that Vasio 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 to one quick follow up to clarify on the voice study, 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, you know, we've made the strategic decision to focus on NDD first and then go do, talk to them about TIW after, you know, as we will have the focus publication and dialysis providers will be, you know, getting that experience. But we don't think we need the voice study for 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 VASIO and Orixia. And as we, you know, look to generics of Orixia coming in pretty soon, I'm wondering if you can discuss, you know, the efforts you've mentioned previously around maintaining those revenue levels as close to as what they are now as possible.

Yeah, it's, you know, Arixia has been such an important part of the past year for us. You know, Nick kind of referenced it. You know, dialysis providers allowed us in to talk about contracting for Vapcio because they needed to get contracts for Arixia put in place. And it really has enabled a lot of these contracting discussions and has been incredibly important for us. You know, we are, Again, we have those Rixia contracts in place. We know that, you know, that providers are looking at that addition of the binders to the bundle and thinking about that process that happened with Senocalcit and Parsabiv and, you know, using those branded products for two years so that, you know, they have kind of, there's a larger number added to the bundle at the end of that two-year process. And we do not know exactly what's going to happen with the and the filers for for Rixia. Right? I mean, there's there were six and the filers, there's no answers 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 at the end of March, if anyone, of course, you've got your your first filer generally and an authorized generic. So it'll be limited competition for most of 2025. I think that allows us to maintain, you know, stronger access for Arixia on a branded basis. All of those pieces put together for 25. We're very conservative as we think about 26 and even towards the end of 25, you know, call it the fourth quarter of 25. 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'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 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.

I mean, we're there as a partner for the dialysis providers with Arixia. Again, I mean, Arixia, long-term, we know that the growth of Akibia and the value we're driving is being driven by Vafsio, right, long-term. I mean, this is, you know, I hate to say it this way, but I think of Arixia as a tool to enable that Vafsio growth, right? I mean, it is something... But 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 Vafcio 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 VAPCO. 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 to first INDs, that would be helpful as well.

Nick, the home question.

Yeah, and so while, you know, 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'll come down to, as we suggested, writing the protocols. But the two populations that come to mind when we talk to physicians is certainly the home slash PD population and the high-dose ESA population. 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, Julian, thanks so much for the question on our early programs. I know that, you know, everyone's focus is on a Vafsio 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 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 pre-IND development now. in 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, you know, is behind 9090. But we are, we're moving that product forward doing CMC work, etc. You know, we had an advisory board meeting on 10108 on retinopathy of prematurity a couple months ago, I guess now. And, you know, I remember texting Steve Burke, our CMO, during the meeting, just talking about how we have to move faster. You know, 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, you know, hopefully as soon after 909 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 Vafsio is available in January. The near and long-term commercial success of Vafsio 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. 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.