Conference Transcript - AKBA 2026-06-04

Speaker 1

All right. Welcome, everyone, to Jeffrey's 2026 Global Healthcare Conference. My name is Roger Song, covering Smithcat Biotech. So it is my pleasure to have the five-side chat with our company, Akibia Therapeutics. And then we have CFO, Eric, and then Chief Commercial Officer, Nick, here. Welcome, gentlemen.

Speaker 2

Great. Thank you.

Speaker 1

Awesome. So, Eric, why not you kick off by giving us some overview of Akibia, where Akibia is, the state of art, and then what should we be looking in the coming month, year?

Speaker 2

Yeah, that sounds great. So, yeah, thanks, Roger, for having us. Thanks, Jeffries, as well. So really excited to talk to you about Akibia Therapeutics today. We are a commercial stage company focused on kidney disease. We have two commercial products. Our key focus is a product called Vafsio, which is approved for the treatment of anemia caused by CKD for patients on dialysis. This is a significant market opportunity. We have a very differentiated product. We launched the product last year. Nick will be talking a whole lot more about that. Our other product is Eryxia. It's a phosphate binder. It's been on the market for some time. Lost IP exclusivity last year. So, going forward, it will be a smaller component of the business, but in the meantime, it continues to generate cash flow for us. We also have a really exciting, advancing pipeline. We announced back in December the establishment of our rear renal disease pipeline, which has two core assets. The first is called Prolisiguat, which is an SGC stimulator. We believe it has applicability in a number of kidney diseases. We're initially evaluating it in FSGS and that's in a phase two trial that's underway. The other asset is what we refer to as AKB097. This is a tissue-targeted complement inhibitor. We believe it has some really unique advantages in that it targets complement locally versus systemically and we can talk more about that. We are evaluating 097 initially in a rare renal basket trial which we plan to start in the second half of this year. And then finally, we have a program called AKB9090. And this utilizes our internally developed HIFPHI technology. And we're evaluating that in cardiac surgery associated AKI or acute kidney injury. And that's in a phase one trial. So yeah, a whole lot of

Speaker 1

interesting things here for us to dig into. Yeah, I like company in the commercial stage, but also you have a significant upside potential from the pipeline i think that applies very well to kibia so why not we zoom in a little bit on the commercial franchise for vaf ceo so you know we see the vaf ceo last quarter back to the growth trajectory um and then it is uh you know we probably just focus on the last year this year because that's within the tadapa period so in second quarter and then the rest of the year, that's still the second year of the PTADAPA. How should we think about the growth trajectory, and then also, you know, you have the TIW seems to be adopted, being adopted, and then how should we think about the growth trajectory compared to the last year and the first quarter?

Speaker 3

Yeah, it's a great question. So, you know, we're not going to get too specific around the dynamics for the rest of the year, but we are pleased with where we are today when we think about that first quarter we saw both of our key indicators of success really starting to tick up the first being you know number of physicians who are prescribing the product so we had roughly 1028 physicians who had prescribed the product that's a 28% increase and that really reflects diversification in our prescriber base moving away from USRC and adding in IRC and DCI and the Vita physicians. We also saw an increase in patients, a 60% increase in patients that are on Vafsio quarter over quarter. So a significant uptake, again, a lot of that driven by USRC, IRC, and VCI, to a lesser extent to Vita. And a majority of those 60% increase in patients came in the month of March. And so really excited that those patients will be generating more months of revenue in the second quarter and moving forward. And so, you know, that was particularly strong as well. As we think about the rest of the year, really, DaVita is the 200,000 patient gorilla in the marketplace. While we have access to DaVita, they're piloting and implementing TIW protocols across many of their clinics. It's a little slower than we'd want. And so it's really going to be a second-half story with DaVita, and we're looking forward to seeing that growth materialize.

Speaker 1

Excellent. I think the two major dynamics here is one is how many patients or DO can access VavSeal. The other one is when they get access, how they're going to stay on treatment or do the refuel. So on the first part, you mentioned the second half of the video is the gorilla there. So you want to ramp up there. How do you think about the cadence of the ramp up? Because I know you have some like a pilot program did with them and then they're happy. But what is the rampa compared to USRC, which is, I think, the biggest advocator there, and then compared to other mid-sized or, you know, smaller than DaVita?

Speaker 3

Yeah, it's a great question. You know, when we think about the mid-sized USRC, IRC, DCI, their clinical advocacy is extremely strong. They've taken a top-down approach. You know, they're sending lists of patients across broad profile out to physicians and, you know, really asking physicians to consider VASC for those patients with anemia. All patients who have reimbursed, not just high-dose ESA, not just all patients, all patients. And so we're really pleased with that. DaVita's taking a little bit of a different approach, a more cautious approach. They're taking the approach of, we're going to make it available, and we're going to let the physicians decide which patients. So it's coming out to be more like, I'll call it a typical launch trajectory, where you have your early adopters that are going in, and then you have folks that are in the wait-and-see mode on the other side. And so that DaVita piece, we expect to come. They continue to make progress on their TIW rollout, which is great. But again, a little later than we would have thought. But that second half growth story is there with DaVita.

Speaker 1

Okay, got it. And then in terms of the refill dynamic, it seems that TIW is really a lot of the deal we want to follow, and then the compliance probably also will be slightly better. So tell us a little bit more about the refill rate here. I know it's still early days, right, so a lot of patients still have that first refill or second. So how do you think about how we see this, you know, churn on those patients already use the VavSeal?

Speaker 3

Yeah, and I always start with dialysis for folks that may not be aware. In dialysis, you have an extremely high mortality rate. Roughly 20% of patients, unfortunately, die each year due to dialysis and CKD. And so that 20%, plus you add in folks that have the ability to get to a transplant, your underlying churn is about 2% to 4% per month of churn, right? And so when we think about refill rates, et cetera, et cetera, it's hard for us to glean from our data which are transplant patients, which happen to discontinue due to death, and which are discontinuing due to the product. But with three times weekly dosing, we've seen a significant improvement in what we call first refill. So we're somewhere between 85% to 90% of folks are receiving a first refill of their prescription for Vafsia when treated TIW. Again, significant improvement over QD. And so happy with that. You mentioned it, Roger. Early days, when we look at that cohort of patients that are on their second refill, third refill, or fourth refill, a pretty small population. We're monitoring closely, but it's not big enough yet to give us a conclusion around where that's heading. though with the early data we're seeing is we're pleased by it our long-term goal is to be kind of in that standard refill rate somewhere in that kind of 80 percentage range 70 to 80 percentage range and the early data is encouraging in that regard the other piece you had mentioned was folks coming back to and restarts starts restarts are so important you know at USRC remember they're the only ones that unfortunately suffered from the larger discontinuations because they were so early to the game with qd irc and dci are tiw from the go so they won't have this issue come through but we are seeing roughly 20 of the patients that discontinued therapy at usrc are back on vacio

Speaker 1

today got it yeah okay so that's uh encouraging and i just want to you know emphasize this patients discontinue or they haven't given you all the compliance is not as high as you want to see 70%, 80%. It's not because they don't like the drug, right? Majority of them are okay with the drug. They may not experience this type of mechanism. Maybe the hemoglobin drop a little bit. They are worried. But my point is, will this TIW and then education and experience will significantly improve to the rate you want to talk? And what are the other tactics or strategy you can implement in order to get the compliance and the refill rate?

Speaker 3

Yeah, and so a number of things. I mean, thank you for the question. Dialysis is a complex care center. You know, you have physicians who are rounding at dialysis clinics. You have anemia managers. Sometimes those anemia managers are within the clinic. Sometimes they're actually centralized, and they're managing anemia with the staff in the clinic. if any member of the care team is uncertain or unaware or misinformed about Vasio that can fall down because it is really a team approach to managing anemia and you had mentioned kind of hemoglobin instability you know we see through the mechanism of action of Vasio that folks starting dose being 300 milligrams daily they're going to need to titrate up it's a titratable drug if people don't realize it's a titratable drug they're gonna see a drop in hemoglobin this they're going to say oh no I need to immediately switch back and so making sure those programs whether it be peer-to-peer programs our medical team educating around dosing it's critical to success to make sure we get every member of that team yeah got it by the way I do

Speaker 1

want to highlight one thing is the team I think you know CEO John and then Nick Eric you have a significant experience in this Reno space. I think, you know, investors have been pretty, knowing this launch in Reno space is not easy. I think the experience the team has, it probably is give people a lot of confidence that you are the right team to launch this. Okay, good. So, and then we move for beyond 2026, because that's the time point you will, out of the Tadapa agreement. And then the two things, people want to ask about the durability and then how the trajectory afterwards and two things I think dynamic is one is that the pricing two is the what is the patient segment you can potential penetrate because right now it's excess is mostly the Medicare but you do have some other people services beyond the Medicare advantage tell me maybe it's from the pricing stuff from pricing

Speaker 3

how we think about this yeah and so we've said a few times before that we're going to see a drop in pricing uh we're going to be esa like pricing uh which means our price is going to come down post adapa um you know we have a variety of different size uh players out there large players it'll be lower pricing than smaller players uh and so but i would use that esa pricing like system out there to gauge price as we move forward post adapa okay and then in terms of access on the

Speaker 1

reimbursement side which what are the you know you're open to everyone or some of them are a little bit more amenable to you as a novel mechanism yeah I

Speaker 3

actually think there's a tremendous upside in the patients available to us so today you have some Medicare Advantage plans covering it some fee for service roughly between 50 to 60 percent of patients have access posted app of every single patient has access so reimbursement is is off the table for the most part even more encouraging is physicians don't have to go through a formulary exception process you know so there's an extra step in there that they have to do they have to enter that patient the system they have to wait for approval all the while the physician is thinking about many things besides anemia and so not having to go through a special process makes those patients more addressable than they are today when you think about patient populations patients, we are very, very lucky to have a broad label. It doesn't carve out particular patient types we go after. In those DOs that are top-down, again, as we said earlier, they're putting every patient on who fits the label or is eligible. In the folks that are not top-down, and specifically DaVita, you may see them start with those most in need, unstable hemoglobin, high-dose ESA. frankly the product works profile it works really well in the QD population who who is getting their dialysis in at home and so an oral therapy for that population makes a lot of sense so you may see them picking and choosing there before they adopt more broadly for stable hemoglobin patients I know just

Speaker 1

from the modeling perspective right so we break down will be pretty sophisticated model I think a new internal model probably even more muscle how do you What do you think about the different, you know, maybe peak or high penetration? Which segment you think, you know, you have more confidence in them versus the other one may take a little bit longer time?

Speaker 3

Yeah, I mean, really the goal is from a clinical advocacy to get the clinical decision makers within the DO to help advocate for the product with their physicians. And in those scenarios, it isn't based on patient population. It's based on do you have coverage and do they believe in the clinical profile of the product broadly. In those that are not doing that, I look forward to those patients that are most in need. Remember, high-dose ESA, hyporesponders, those with an unstable hemoglobin, they're a significant percentage of the population. And so I don't think we're niching ourselves in any way by focusing on a particular segment.

Speaker 1

Okay, good.

Speaker 2

And I think we were pleasantly surprised by that, too, out of the gate. You know, we expected maybe kind of what you're getting at is certain niche populations would adopt first, but it was more broad than that.

Speaker 1

Yeah, that's to echo, thank you, Eric, and then echo Nick's early point. It's a broad label. It's not like you have any restriction on a certain population, but just, you know, in reality, which one may adopt earlier. But in the real world, actually, they are not discriminating any of the population. Okay, and then speaking to the label, you do have some other new clinical data going to supplement or even enrich the label, so voice and then the vocal. So work us through why those data points will be meaningful and then how this will impact the launch, particularly after the DAPA.

Speaker 2

Yeah, no, thanks for the question. I mean, it's always been a key element of our strategy to continue to generate data post-approval to continue to demonstrate ways that the product is beneficial to patients. So we have, you know, two studies we can talk about. You know, I'll start with the vocal study. So that's being conducted in DaVita clinics. It's TIW dosing where we're looking at Vafsio versus the standard of care, evaluating safety and efficacy. You know, notably, there is a sub-study as part of this trial where we're looking at the characteristics of red blood cells. And so we know that red blood cell quality is important when you look at disease severity for anemia caused by CKD in patients. And so we'll be looking at a number of measurements there, which, you know, should be really interesting to dig into. That data will be available in the fourth quarter of this year. The other trial is the VOICE trial. This is a collaborative clinical trial we're conducting with U.S. Renal Care, led by Dr. Jeff Block there. 2,100 patients we fully enrolled in June, so we'll have data in the first quarter of 2027. And looking at two key things here, one is all-cause mortality, the other is hospitalization rates. I think the hospitalization rates component is particularly interesting. For those who aren't aware, when dialysis patients go to the hospital, the DOs share in a portion of those costs, and so if we can show that the hospitalization rates you know, are lower with Vapcio, you know, clearly, you know, there's, you know, an economic value to the DOs. Of course, most importantly, it's best for patients.

Speaker 3

You know, I think that data, too, is going to be confirmatory. When we think about the data that we have at ADC in the winter, we presented this health economic data that showed a 7.7% reduction in hospitalization events, a 16% reduction in hospitalization days, and And one, good for patients to keep them out of the hospital, but two, when you look at the dollar savings per year, $3,700 per year savings, you know, if you look at someone like DaVita that has 200,000 patients, even if only 50% are in these value-based care programs, that's 100,000 patients that could receive, to DaVita, $3,700 of value. That's a significant opportunity, the voice study confirmatory to that at USRC.

Speaker 1

Excellent. I think we talk a lot about the dynamics, clinical, and then strategy. And then you, on the Vafseal, you have another product, I think, Eric, you mentioned earlier, Rexia. So I always think this is like a Christmas gift to you because you have been out of the L.U. for a long time. It's a long Christmas. So it seems now we have a few more generics coming. So I know you're internally pretty conservative. Same we are. So it's like we don't want to make this as the, you know, we're assuming nothing is going to enroll. So how should we think about, you know, my question is actually, you know, how much the dependence you need for your current financial balance sheet to rely on this orexia versus that field is catching on to get to generate the revenue.

Speaker 2

Yeah, you're absolutely right about this being a gift. You know, we have seen the aryxia erosion, you know, coming for, you know, for some time, and it did take longer to materialize than we had planned. I mean, we generated $180 million in aryxia revenue last year, which was great. Yeah, I mean, to your, you know, the core of your question, I mean, we haven't guided on, you know, run rates specifically, but, you know, we do remain, you know, conservative when we forecast aryxia. we take into account those revenue forecasts when we budget our expenses from a forecasting perspective.

Speaker 1

Got it. And then in terms of the budgeting, because we are exiting the Tadapa and then you're moving to pretty broad access, how do you think about the GNA or SGNA and then any guidance around that in the near term and then longer term?

Speaker 2

Yeah, a couple of points. One, Eryxia does not require Salesforce effort. So, you know, that is really working on its own. The sales and marketing activities are, you know, pretty much exclusively focused on Vafsio. You know, the good news is at this point in the launch, you know, we're past things like, you know, that initial spend for, you know, market awareness of the product, right? I mean, you continue to invest in these things, but, you know, that bolus is behind us. You know, we can, in fact, be, you know, more targeted in the work that we do on the sales and marketing side at this point in the launch. So, you know, we don't expect increases from an SG&A standpoint and think that that, you know, leverage that's in or the infrastructure that is in place now is highly leverageable.

Speaker 1

So you don't think you need to significant or meaningfully increase the infrastructure even outside of the Tadapa? That's correct. Got it. All right. And then maybe we use the rest of the time to talk about your pipeline, which honestly we think is very, very interesting. and then obviously it's not in the stock or too much in investors' expectation, but this can be a significant upside potential from here. So you have quite a few, right? So maybe just walk us through each one, and then what's the strategic priority there, and then maybe a couple of points in the question afterwards.

Speaker 2

Yeah, yeah. Yeah, I mean, we believe there's a lot of potential here too. And stepping back strategically, it just makes sense that we're in these areas given our expertise in kidney disease. So, yeah, maybe I'll focus more on prolisiguat and 097 in the interest of time. Prolisiguat, as I mentioned, it's an SGC stimulator. So, by definition, it is stimulating soluble guanylase cyclate, which binds with nitric oxide, which creates CGMP, which increases vasodilation, blood flow, reduces inflammation, reduces fibrosis. We know that the nitric oxide pathway is dysregulated in a range of kidney diseases, including FSGS. And so our first trial with this drug is a Phase II randomized placebo-controlled double-blind trial evaluating prolissalglide in FSGS. We're planning to enroll up to 60 patients. We'll look at UPCR levels. there will be a crossover so placebo patients will cross over to drug after 24 weeks and so you know once that final placebo patient is crossed over we'll be able to unblind the data yeah but you know FSGS about 40,000 patients you know high unmet need characterized by scarring of the filtering units within the kidney so yeah the enrollment has been going well we're really pleased with it and look forward to continuing to update the street as we progress. Excellent.

Speaker 1

Maybe just on the expectation, Peresquat, you are running a phase two and then we do FSGS, it's kind of active out there. So how do you think about the profile you want to achieve before you can move forward and then how do you think of the competitive landscape and then what you want to be landed at? Yeah, we'd like to see a statistically

Speaker 2

significant difference in terms of the reduction in new PCR levels between us and the treated group and the placebo group. I also like to see an increased proportion of partial and complete responders versus placebo. Yeah you know there are other entrants in this space you know FSGS is a heterogeneous disease you know we think there's going to be room for multiple treatment options and you know from an MOA perspective you know we're the only SGC stimulator attacking FSGS at this time.

Speaker 1

Okay, good. Yeah, I look forward to that data. Our data will be sometime next year?

Speaker 2

So we haven't guided specifically on the timing of that data. You know, we'd like to see how the enrollment continues to progress, and then we'll be able to get more granular on that time.

Speaker 1

Okay, good. And then you did acquire a complement inhibitor, which is differentiated in terms of the targeting, the tissue targeted. So, work us through the mechanism and then why it's tissue targeted, and then we know we have a lot of complement inhibitor out there, so why do you think this can be very differentiated here?

Speaker 2

Yeah, we're really excited about this asset. So, as you mentioned, it's a differentiated complement inhibitor in that it targets the complement system locally versus systemically. You know, traditional approaches are more systemic in their nature. You know, just by way of background, you know, there are a number of complement-mediated diseases, many of which are in the kidney, and, you know, what happens here is the complement system becomes dysregulated. The complement system is part of the immune system, so the way that the complement inhibitors work is by binding to the complement proteins and halting that cascade of cell destruction. So 097 is a fusion protein. It binds with high affinity to C3D. We know that C3D is present at sites of complement activation, and so that, you know, is part of the MOA that allows for that targeting. You know, patients are going to be on these drugs for a long time, and so, you know, the less that you can be stressing, you know, the immune system, the better. And we think there's also advantages from a convenience standpoint as well when we look at how we think about dosing of this product, you know, down the line. the trial that we are evaluating 097 in as I mentioned is a basket trial we plan to start that in the second half of the year we're looking at three rare renal diseases initially c3g lupus nephritis and iga nephropathy we'll be looking at protein area levels as you might expect and we'll have data from that trial in 2027 okay so it is a basket

Speaker 1

trial you know I think yeah they all belong to rare renal disease and some of them are a bit more and then than the others how should we think about the data you're gonna get present on 2020 in 2027 and then what you want to achieve and then how you're gonna select the indication from there if you want to select the one from there.

Speaker 2

Yeah, so we'll be looking for a clinically meaningful reduction in proteinuria. We'll be looking at some pretty interesting biomarkers. One is C5B9, and so that measures the levels of complement activity within the kidney, so that'll help us assess how the drug's performing there. From a market standpoint, any and all of these These are very interesting and attractive places for us to be. Some more competitive than others. We see an unmet need kind of across the board and certainly places where we can play. I think one of the benefits of this type of trial design is that it does give you that flexibility to, should you see interesting data from a particular indication, move forward. You don't need to wait for that trial to fully, you know, be completed before you go to the next move.

Speaker 1

So the expectation is when you have sufficient data from the basket trial for one or more indication, then you can decide it to the next step.

Speaker 2

We have that optionality, which I think is great.

Speaker 1

And then maybe just one more pipeline, throwing the rain here. 90, so what is that really try to address, and then, you know, I asked earlier, so how you're going to prioritize all of those pipelines? Seems you want to go in parallel, and then is this the number three or lead, the third lead kind of pipeline?

Speaker 2

Yeah, yeah, and this one's a little bit earlier. So, yeah, AKB9090, you know, as mentioned, a HIF, you know, PHI. You know, acute kidney injury, you know, if you look at the number of cardiac surgery-related procedures over the course of a year in the U.S. I mean, there's about 400,000 of those. Our research indicates that up to 30% of those cases involve AKI, so this is a huge problem. There's no drug specifically approved for cardiac surgery associated AKI. So the phase one, you know, as you'd imagine, is more focused on safety, so SADMAD, you know, PK, PD. You know, we will be able to evaluate, I think to your question, EPO, right? So we can see whether there's target engagement in the kidney, you know, is HIF being stabilized and EPO being produced. So, again, that's in a phase one, so a bit earlier, but we'll have that top line data in the first quarter of next year.

Speaker 1

Excellent. Last 30 seconds, Eric, you want to wrap this up, and then maybe financial-wise guidance, anything you want to highlight?

Speaker 2

Yeah, from a financial perspective, you know, in our Q1 earnings based on our operating plan. We have at least two years of cash one way. In terms of key catalysts and milestones over the next, you know, 12 to 18 months, there's a fair amount. You know, starting with Vafsio, we'll, of course, have the continued quarterly revenue updates on the product. We have the vocal data in Q4 this year we mentioned, and then the voice data in Q1 of next year. Turning over to the pipeline for AKB 097, starting that basket trial in the second half of this year with initial data to come in 2027. As we discussed for Polisiglot, as we continue to advance enrollment, we'll have more granular timing guidance on that data. And then rounding out the pipeline for AKB 9090, we'll have that phase one top line data on the AKI program in the first quarter of next year.

Speaker 1

Excellent, thank you Eric, thank you Nick, thank you everyone listening and watching.

Speaker 2

Great, thank you.