All right, thank you everybody for joining me. My name is Laura Chico, I'm a Senior Research Analyst at Wedbush. It is my great pleasure to kick off our ASN Rewind event featuring our starting presenter, Mike Raab from Ardelyx. Thank you, Mike, for challenging technical issues, but I'm glad we were able to kick things off here. Thank you today for joining us. I appreciate it. Of course. Happy to. You know, since we're on the heels of kidney week, the first question that we're going to ask everybody here is what were your biggest takeaways from the ASM meeting? I guess as it relates to XPHOZAH specifically, you know, whether it's data, sentiment, something else, what's most important for you coming out of the meeting today? Laura, actually, I think there's a meeting that you held maybe three, four years ago where we were using the term are we on the cusp of a renal renaissance? It really seems to be the case, given the attention that was there, you know, across the different aspects of renal disease and drug development within the space. It's, you know, it's been a long haul to get here to get the attention that I think this area of human health deserves the attention on. As it relates to XPHOZAH, you know, we obviously have made decisions we believe are in the best interest of patients that reflect exactly what I just said and what we saw in the booth and what I've heard from the team that were there is the amount of traffic that was going through, both from those who are currently using XPHOZAH for their patients and those who are finding it frustrating, finding access for it was significant. Right. I mean, the booth traffic, both in our medical affairs group as well as in the commercial booth, was spectacular. Our exhibitor spotlight was standing room only. Our training efforts within the booth as well. I feel very good about it. Certainly I wish we were in a different place so that we did not have to go through the challenges of asking the questions of why we have done what we have done. I think what we saw on the floor there at ASN is exactly why we have. Okay, that's great. Kickoff here. And you know, one presentation from Ardelyx that struck me at ASN is the real world effectiveness presentation on XPHOZAH and the treatment satisfaction presentation as well. So maybe walk through some of those highlights, especially now that, you know, you are accruing experience with XPHOZAH. Again, any highlights there that investors should be mindful of? Yeah, I guess two fundamental things for me. Right. And it's, it's one that XPHOZAH clearly is having a huge impact on those who are taking it to lower their serum phosphorus. Right. The real world evidence demonstrates that we're actually getting patients to serum phosphorus levels that previously were unattainable with binders alone. That is extraordinarily positive for the patient population and the treating physicians and healthcare practitioners who follow these patients. I think what was interesting about the patient satisfaction survey is that a lot of the concerns that we hear from, frankly, analysts as well as investors is the side effect profile. We know that there are loose stools. This goes back to even studies that we did post our phase III program in our pre-phase IV sort of efforts that we undertook with AMPLIFY, OPTIMIZE, as you know, which is once you start taking XPHOZAH, if you get off your laxatives, bulk laxatives, all of those things, and use XPHOZAH alone, it actually becomes a new normal. Certainly there's more frequent bowel movements, but given that this population has been chronically constipated, for them to suddenly have more frequent bowel movements is something a bit of a surprise. Now if the clinicians are telling them, hey, listen, this is what's going to happen, get off your stool softening medication, laxative, et cetera, and this will become a new normal, I think is exactly what we're saying. Yes, we know that the side effect profile is directly correlated to the pharmacologic impact that this drug has, as well as when you get your patients prepared for what's coming. It's not as much of a concern over time for sure. Okay, and maybe I'll pivot away from data for a moment. Just touching on the appeals court hearing. This was back in late September if I'm remembering correctly. You know, we certainly have a decision from that case coming up. How should investors think about the range of outcomes though from the appeals case that's ongoing? I think, as you've heard me say, Laura, throughout is anything that turns us back to having coverage in Medicare is a free call option. Right. I think as you look at the 40% of those that are non-Medicare, you know, that makes up 220,000 patients. So I think about that as our new TAM. And how do we ultimately get to that? $750 million in that TAM is ultimately at our WAC over time, assuming five scripts a year, we may do better than that. But if you look at binders, which is the proxy that most people will use, that's about five a year. You divide the $750 million that we've guided to for peak and that's 12,000, that's 60,000 patients at that WAC price, which is $12,500 per annum with that. So it's 30% of the 220,000 TAM to get us to the $750 million. To me that seems absolutely approachable and doable within the patient population that we're seeing while we continue to be able to service those who are unable to pay and fall within Medicare, and if they meet our criterion in patient assistance, they will get non revenue drug. That was our commitment going forward, is that we would make sure that you as a treating physician didn't really care about the TAM and whether or not I had Medicare or not in terms of coverage as it relates to the court case as a free call option. You know, we've gone through the process which is, you know, a uniquely American opportunity for us to petition the government for our grievance and try to find remedy for those who we represent. That's an incredibly powerful thing that we have. We don't know when the court will read it out. Right. It can be tomorrow, but it could be at some point next year. Okay, so kind of a fluid decision. If the benefit were legally reinstated, I guess, kind of from a mechanistic perspective, what would that look like as you kind of transition back? I apologize if that's a rudimentary question here. Yeah, I mean, what I would suspect it would be is like any new drug launch that suddenly gets Medicare coverage, sort of when we launched the drug initially, where, you know, payer is going to be, as we are now, non-preferred, non-formulary, and you have to go through a prior authorization. I do not think it will be anything different than what it previously was. We saw what that looked like in 2024. Okay, okay, I think that makes sense. Kind of following off of the litigation question, dialysis centers specifically have undergone a lot of changes and challenges here. From your vantage point, I'm curious, in this first year of transition in the new payment system, what have been some of the biggest challenges that you're hearing from dialysis providers? I think that's something that often gets overlooked in the exposure story. This was not only a huge adjustment for Ardelyx, but also the providers and the patients. Any comments? It continues to be right. We're not done with the transition. It's another year of it, at least through the TDAPA period for binders. There are patients that aren't getting what they need. They ultimately need to go out and either pay cash for a calcium-based binder or get over-the-counter Tums, which we know is the wrong thing for patients. You need to manage phosphorus. Phosphorus needs to be lowered. It's an independent predictor of morbidity and mortality in these patients. Just because of the peculiarities of the way the system is working, many of these small independent providers are unable to meet, as I understand, the ability to have, whether it's a pharmacy in their sites or set up the relationship with a mail order pharmacy to do these things, which is pretty complex stuff. I think for the big providers, it's more second nature for them. Maybe it's a bit easier. Even so, you know, whether it's the physician that continues to have the say on what phosphorus lowering medications are used within a protocol, whether or not there's actually a protocol, all of these things are different, whether from provider to provider. The confusion it causes in the field, both through the treating physician, all the apps that are watching and waiting and taking care of these patients, and certainly the patients and their caregivers as well, is a huge amount of turmoil, which is what we predicted and what we expected, which is why we wanted to stay out of it. Okay. That might kind of dovetail to the next question I had for you, which is, you know, it's still realizing not long time has transpired since this turned over. Are there any, I guess, unanticipated learnings that you've observed so far or anything you would have done differently in this first year? No. I mean, for me, there's a part of this that is. It's sad, right? I mean, to see what these patients are going through, where we as a country are putting a huge investment in trying to bridge these people who've sadly, their kidneys have failed, that the country has stepped up back to the Richard Nixon administration to protect and care for these patients. Right. We, we've invested a lot as a society in trying to help these patients bridge themselves to transplant. Sadly, we don't have enough transplants. It ends up being a chronic therapy versus a bridge. It is incredibly taxing on these patients. We just added yet another taxing issue on them in this bundled period. How we ultimately work through this and fix the system for these patients is, I think, incumbent on everyone involved in the dialysis process, whether it's providers, manufacturers like Ardelyx and others. There has got to be a way to fix the system and these patients are suffering. To me, it gives me that much more resolve for what we've done in the approach that we have taken, because we cannot be part of a system that we think is ultimately deleterious to the patient. Unless that seems to be a different process or that it will change, I don't see manufacturers, at least like Ardelyx, participating in the way if in fact you can continue to meet the needs of patients. You know, it's a moral and ethical obligation in a way that I feel. That we are kind of related to that. I think one thing that stood out from our prior checks is the positive impression of XPHOZAH from physicians. Has there been any change, I guess, in physician perspective of XPHOZAH now in this different regulatory environment? Only as I'm thinking about the earlier commentary around relaxed use of laxatives and stool softeners, it would seem like I'm Not sure that any perceptions or perspectives have necessarily changed. Okay, what is changing, and this is, this is the frightening part of it, is sort of giving up, saying it's now in the system, I'm out of the loop. Right. And as a treating physician or HCP, and that sort of giving up of this incredibly important part of patient care is still, is troubling to me because first, do no harm is what every treating HCP commits to. And we know that ultimately you go down a path of this. If you look at the examples we've shared before with Parsabiv, during the TDAPA period, there was, you know, a nice increase in a very good drug that helps secondary hyperparathyroidism. Post the TDAPA period. What happened is a significant decrease in utilization, an increase in thrice weekly, which is not what was ultimately the approval that Amgen got for Cinacalcet thrice weekly oral generic Cinacalcet. What you see concomitantly is an increase in parathyroidectomy, which we shouldn't be doing in our society today when you have options like Parsabiv to treat these patients or more frequent oral Cinacalcet as we have available for these patients. Instead we're doing something that is not quite barbaric, but it feels like it at times that we're putting and then disproportionately Black treat patients. If you look at all the data from SRDS and other sources that we see an increase in these populations post TDAPA period. I worry about post TDAPA for our patients that need phosphorus management. My commitment and our commitment to be there for them pre and post the TDAPA period to help them. That kind of brings me to my next question, and you know, we still do periodically get this from investors, is that revisiting the decision not to enter TDAPA, and I think you kind of laid it out a little bit here with the Parsabiv example. What was the advantage to not entering TDAPA with respect to XPHOZAH specifically? Probably the simplest advantage, and there's more for sure that I'll touch on, is you go into a TDAPA period, you're going to discount your medication to the providers as they then provide it to the patient. That kills best price. It's a downward death spiral in terms of best price for Medicaid. Right. And that is part of our non-Medicare population. In order for us to protect, if you will, as well as we could, that non-Medicare population, this was a decision we felt was requisite for us to continue down that path. Also to make sure that knowing what the precedents were of Parsabiv, where in fact there was a base rate increase for Parsabiv, there isn't with XPHOZAH. Just to remind everyone, in the TDAPA period that's ongoing right now, the only base rate increase medications were the binders where in their great wisdom, CMS carved XPHOZAH out separately and there would not have been a base rate increase brought to those providers for utilization of XPHOZAH. It would have been literally crazy to go into the TDAPA period knowing what the end game looked like, knowing that there was none of the sad but at times perverse incentives that are structured within a TDAPA period that would change the utilization of XPHOZAH. I think people ignore that fact. That was part of the PPS as XPHOZAH was treated differently, PPS changes every year. You know, we will continue to monitor the prospective payment system as we look at the evolution of it over time and if there are opportunities for exposure to do something within whatever that might look like, of course we consider it. The TDAPA period as it was established for binders and XPHOZAH made absolutely no sense for Ardelyx to participate in that. Okay, maybe walk through in a little bit more detail your assumptions around the current TDAPA period for the binders. I think there was a little bit of a prior precedent for that period to expand. Can you walk us through what your assumptions are around the termination of the TDAPA period for the binders? Yeah, I mean, I think as we all await the final PPS for this year, normally it's out by now, but I think with the government shutdown and everything that's been delayed, obviously, I mean there's still things that are coming out from the government, but the PPS has yet to emerge. I think we'll all wait and see. The current assumption is the TDAPA period lasts two years. Right. There's two components of it as it relates to how DOs are looking at. One is you look at the utilization of what binders are in that period of time that will dictate the base rate increase post the TDAPA period as it's calculated and it'll be, you know, couple five dollars, whatever it might be per session. They've also benefited from a dispensing fee during the TDAPA period that they get a certain amount of money for dispensing the binder because of the challenges that they face, whether it is a direct pharmacy in their facilities or a mail order pharmacy dispensing the drug to the patient, all of which is in many ways new to these patients and certainly a challenge for them. That is what the current TDAPA period is. The base rate increase, as I understand it, would be based upon the utilization of the binders, not the dispensing fee. The dispensing fee goes away post the TDAPA period. That then says, gee, what is the lowest common denominator or the most affordable or the cheapest phosphorus lowering medication that a provider can say to me, the patient might go and get this and it's either going to be calcium acetate, which is the cheapest and of course not the best in terms of we're trying to stay away from calcium writ large or sadly the worst would be Tums over the counter. It will be interesting to see kind of what evolves there. You kind of walk through this a little bit with respect to your XPHOZAH peak estimates and I think kind of in light of those transitions occurring with the binders, but this is also another one that we feel quite often from investors and it is around those assumptions around your peak uptake for XPHOZAH. In the scenario where the binders come out of TDAPA, does that influence or I guess change at all any of your confidence in the scenarios you walk through and just kind of revisiting that map? That might be a little bit helpful? Sure. I mean again, think about unintended consequences of during this, this two year period. One, as a provider I get a dispensing fee and I also get the potential base rate increase two years later. What does that mean post those two years? After those two years I'll stop focusing on that and hopefully I go back to focusing on the fundamentals of having serum phosphorus be lowered in the manner it can. We'll still be there, right? Ardelyx will still be there with our patient assistance program and our ability to adjudicate whomever comes through the program as whether Medicare or non- Medicare. That won't change and thank you. Thankfully I believe that would become more appealing to folks because we would be there to help ultimately get serum phosphorus to the levels it needs to be. Time will tell. That would be my belief is that it becomes less of a burden for the providers because they're focused right now on what's happening during the TDAPA period. They're not focused on us and XPHOZAH. Those who are are getting benefit of it and we're seeing serum phosphorus levels decreasing. Those patients are actually getting the access. I think as you heard during our last earnings call, when you look at both our non-revenue and revenue drugs, more patients have access today than ever. It's just not as transparent just because of the way scripts are gone for binders. Right. For those that are in Medicare and our non-revenue prescriptions are not visible either. Those aren't reportable. From my perspective, the fact that we are servicing as well as we are those who are on Medicare and those who are not bodes well, I would hope, for the post adaptive period. Okay, this is a little bit on a tangent but you recently announced a bit of a pipeline expansion into a new program. I'm curious just in light of the XPHOZAH experience, how are you thinking about indication selection for the pipeline? I would love to get your thoughts a little bit there more directionally. You mean are we crazy enough to do another hyperphosphatemia drug? I don't know if I'd put it that way. Yeah, I mean patients first, right? I mean trying to help patients as much as we can is the privilege of being in this business. Of course we're going to look at it. It's a far more soluble, far more potent molecule than Tenapanor. What might that mean? I think as you've heard me speculate, we don't know because that's why we need to do this work. This is a non-absorbed drug so PKPD is not the same thing for other small molecules. We actually learn a lot through the biological exploration in preclinical models and ultimately in healthy volunteers and then patients in subjects. That's how we learned, one, that we have the pain benefit in IBS-C. We thought this was just sort of an osmotic benefit of blocking sodium. You get water that follows salt and it ends up being. No, it actually has a benefit in pain. And then phenomenologically, we observe that we also lowered phosphorus. What else might we observe? You know that the mucosal layer in the epithelial on top of the epithelia in the GI tract is variable person to person. We know that microbiome is variable person to person. Does solubility, does potency change the benefit that we see across those lower or non responders, which of course we have. As you look at our clinical programs, that'll be interesting to see. Are there other indications where there may be a benefit? Without question. If you look at just the biology around NHE3, there may be many other things that we would choose to explore. It's premature and I know folks want an answer, but this is the way we developed Tenapanor. We followed the science and that told us a lot. Ultimately, that helped inform our clinical development program from which we then learned more. That's the approach we're taking with 531. Okay, makes sense. Just remind us, I know that's still early days, but IND submission timing? I mean, I would expect you get updates next year for sure. We're not going to spend a year not filing, not doing anything. I think, you know, 2026, I think you'll get some more perspectives on where we're headed with 531. Okay, that makes sense, I guess. One other one here that we've got here. Just in terms of the exposure patients and physician prescribing, would you anticipate physicians increasing their amount of eligible exposure patients over time as they gain familiarity with the drug? I do. Right. I mean, it's. For the TDAPA period, we're still early in the launch. Right. In that, you know, the natural tendency for a treating physician, HCP. I've been banging my head against the wall with these 20 patients who have really high phosphorus. They focus on those who are the most challenging and we're seeing remarkable results. You begin to move downstream. In the midst of this, there's a TDAPA period. Suddenly you're focused on other stuff because of what you're being told to do by the DOs that you practice within. That's added yet another dimension as we've been talking about. I do think as you look at the AMPLIFY trial and what we've been able to demonstrate in the work that we've done is whether alone or in combination at current doses of binders or decreased doses of binders, you finally have a polypharmacy approach that's going to allow you greater success potentially in a broad swath of your patients with hyperphosphatemia to get them close to or to normal, which before with binders alone you were completely unable to do. I do think it will evolve as we continue in the approach that we've taken for them to move lower into the, into the 5.5-6.5 to the sevens that we see being treated today. Okay. Okay. So keep watching that dynamic unfold. I'd like to ask you, I know we're focused on ASN and XPHOZAH, but I would actually like to sneak one in on IBSRELA. Of course. You know, one thing we noticed recently in the IBSRELA script data was the increase in NRX numbers. And it certainly seems to be taking off quite a bit. Kind of coincides with some of the changes you made structurally with the Salesforce, MetaPhairs access. So talk about right-sizing the organization, and I guess kind of, you know, would you. Well, let's start there. Is this an effect that we're seeing kind of translate from the changes that have been made so far? Sure. A part of it, without question. Remember, we've also added our field access managers who make sure that the pull through is there. The ABDS salesforce is filling the top of the funnel. We now have built a 20-plus person field access manager team whose sole responsibility is to work with the offices that are working on prior authorizations to make sure the pull through to our specialty pharmacy network is as seamless as possible. Hitting both the top and the bottom of the funnel is critical. If you look at what our marketing team has done, obviously revamping and improving the messaging around the omnichannel approach that we take has also been a component. It is the totality of the program, I think, that results in what you're saying, but also experience. I mean, even though we're at year three, it's still relatively early in a product. In a program like IBSRELA, where you have the physicians that we call on, it's 14 or HCPs we call on is roughly 14,500 of writing HCPs. The other 50% is almost 175,000 or more treating HCPs in the lower 50% of the HCPs that write. We're seeing good uptake across the board, particularly in the areas where we call. I think the omnichannel marketing efforts that the team have put in place are having a significant impact, as you note. Okay. Would you consider revisiting further expansion whether it be on the medaffair side or Field Access Salesforce? Yeah, I mean excellent point on medaffairs because that's also another area of focus that we've begun to bring in new lead for, for Medical Affairs. I think that all is a critical component. To answer your question directly, we'll always consider these things but we need to keep in mind disruption, all that kind of stuff as we look at when and where and how optimization or increase in investment in the in field facing, customer facing folks is requisite. Okay. We'll do it in a thoughtful manner if we do any addition. Okay. In the last two minutes I know we started off with key emergent themes from ASN. I'd love to kind of close out with what you're most excited about for Ardelyx in 2026. In 2026 I'm looking forward to how we start the year. Obviously the way looking at the trajectory that we're on for IBSRELA, it is the machine that's driving the company. It is going to provide us the opportunity to do 531 and more exposure is going to continue in the confusing place that it's in. Look at how it's doing in the context of the TDAPA period and what you and I have discussed. Look at how well XPHOZAH is doing and I think people don't focus on that. They focus on the slower growth rate. Yeah, slower growth. Growth rate in a terrible circumstance. I am excited about both. I think what we're doing for the company and building this enterprise into something that's sustainable and significant. Very few of us in our careers get to do this and sure it's a tough road to hoe, but that's what we signed up for and that's what we believe is the right thing to do for our patients, particularly those on dialysis that don't have other choices but this. You know we're very fortunate to be in a position that we are. I think 2026 is going to be a breakout year for the company because I think the show me story, I think we've shown you and everyone else, in fact, we can deliver. I think it's going to be more about delivering versus people kind of reflecting back in sort of a show me point of view because if anyone, and I'm biased, of course, I think we have demonstrated our ability to navigate complex and challenging environments to make sure that our patients get the drugs that they deserve. I hope and I expect that we will begin to get that attention in 2026 more than we have in previous years. Always a pleasure to have you, Mike, and I always appreciate the perspective. I think with that, we're going to wrap up the session, but thank you so much for joining us today and best of luck for the remainder that you're here. All right. Thanks, Laura. Thank you, everyone. Thanks, Mike.