Okay, why don't we go ahead and get started. My name is Chris Raymond. I'm one of the biotech analysts here at Piper Sandler. Very pleased to have with us the next presenter here at our conference, which is Ardelyx. We have with us Justin Renz, who's the COO-sorry, not yet CEO-COO and CFO, and then also Eric Foster, who's the Chief Commercial Officer and newly joined the ranks here at Ardelyx. So just to go over the format, this is a fireside chat, very informal. I've got my questions, but if anybody in the audience has any, please just raise your hand. I'll make sure it gets asked and answered. So we have a ton of questions, lots to dive into. Maybe Justin or Eric, if you wanted to, for investors who don't maybe know the Ardelyx story, give us your elevator pitch, setting up the company and the premise behind Ardelyx and what you guys are trying to do. Thanks, Chris. Great. Good afternoon, everyone. Thank you for having us, Chris. Great conference, great schedule. And to my friend Mike Raab, our longtime and only CEO, I'm not gunning for your job, so you're safe for the foreseeable future by my count and probably from Eric's as well. So thank you. Mike actually helped write the investment thesis for Ardelyx back in 2007. We incorporated in 2009, and the goal was for novel oral small molecules to meet unmet medical needs in areas where there's clear need for medical innovation and assistance. And so we've done that now twice with two drugs that are commercially available. One is IBSRELA. It's for adults with irritable bowel syndrome with constipation. We launched in April 2022. We've been selling that now quite well. We've had progress over the last nine quarters where we've had consecutive quarter-over-quarter revenue growth and did just over $40 million in Q3. Our second drug, which was approved in October of last year, XPHOZAH, is for end-stage renal disease patients on dialysis for hyperphosphatemia. That has been a very good launch. We've been now selling it for a year. In just this past Q3, we did over $51 million in revenue. We have a very strong balance sheet. We finished the third quarter with over $190 million in cash, and we borrowed $50 million from our lender in October. Pro forma, we have $240 million in cash, and that's interest only till July of 2028. We feel we are now poised to do well. We're looking to add and build a great company. We've begun looking at our pipeline both internally and sourcing externally. And so the goal is to focus on commercial execution led by Eric Foster, who joined us in August for those two products I mentioned, as well as find additional complementary candidates for us to grow. Okay, so I want to ask Eric a question. You joined in August. Your history at Horizon, obviously you led a very successful business there. I suspect you had a lot of options. And knowing the XPHOZAH CMS outcomes and what was well down the path of potentially happening with binders going into the bundle and all the stuff that's going on with CMS, you must have sort of understood this. There's obviously more than just the renal business to Ardelyx, but just describe your decision, Eric, with the options that I'm sure you had to join Ardelyx. Yeah, thank you. Great to be with everybody today. Very kind of you to say that I had lots of options. I'll take it. But in all seriousness, for me, what's most important is who I work with. Had a chance to meet Mike, sit down with him, had a great conversation, meet the rest of the executive team, and it really stood out to me, it's a great team. So first and foremost. The other thing is grit and determination. This company's been through a lot. If you know the story of XPHOZAH and what they had to overcome and accomplish to get it to market, it really stood out. That's something that I hadn't really been around too much and was really exciting for me. The other is the products. I think two novel MOA or two novel products with true unmet need in the markets that they compete in was something that really stood out for me. And then lastly, the ability to come in and have impact. So those were the things that I was looking at. When I think about that, Ardelyx more than exceeded my expectations. And you mentioned XPHOZAH and the risk there. So of course there's risk. There's risk with every company that you go to. And when I evaluated the opportunity, I saw significantly more upside than I did downside. Excellent. Okay, so maybe let's just jump into XPHOZAH, probably one of the more interesting sort of pathways commercially. With all the stuff you guys have been through, you mentioned grit. I can't imagine a more arduous path to getting where you are today. And there are still some barriers here. But I think most folks are familiar, I think, with the story. Really the first truly novel phosphorus-lowering agent approved in literally since Renagel a couple of decades ago. We've done enough survey work, and I think most folks who've done their own work understand this is still, even with all the reimbursement challenges that are on the horizon here, docs look at this as one of their more desired therapies in the space, if not the most interesting and expected uptake drugs in the space. So we've got a situation obviously happening potentially on January 1st where binders, including XPHOZAH, will be put into the bundle. And CMS obviously decided to reinterpret the spirit of TDAPA. You guys have mentioned KORSUVA as an example of what might happen if you go down the path of TDAPA. Maybe just explain this whole TDAPA. I try to talk to investors about this, and I get people with their eyes glaze over when they talk about bundling and TDAPA and all the CMS jargon that goes along. But maybe just level set for everybody the issue that you're facing here on January 1st. Sure. We'll certainly do our best in a sound bite, so TDAPA was put in place essentially for dialysis patients that, since we have a level playing field, and so they would have access to all medicines, and the motives were pure. Unfortunately, it's the unintended consequences of said decision that is what the real world is facing, and so KORSUVA is a tremendous example. Very good drug approved for pruritus, and essentially what happens is dialysis organizations have protocols that they follow, and they have to have this across their organizations, and they prioritize, unfortunately, sometimes medicines that are less innovative and less expensive than more innovative and more expensive, and so we did not want to fall victim to being a protocolized medicine that is not decided on investors and nephrologists and the patient. So our desire was to absolutely keep the decision-making between the nephrologist and the patient. And the only way we found we could do that was to stay out of the ESRD with the TDAPA program. Okay, but so, help explain this to me and to others. TDAPA, obviously add-on payment, right, is a cornerstone of that acronym. What specifically would have damaged XPHOZAH's business if you would have applied for that? Sure. So in the TDAPA period, the goal of CMS is to evaluate the utilization of various medicines. So during this period of time, the dialysis organizations would be the buyer of our drug, prescriber of our drug, the distributor of our drug. Okay? And And so as proposed, it would be ASP plus zero. And so they would have to buy our drug, inventory our drug, and then distribute it. And they will be doing that for binders. And that's why you've seen binders contracting with the dialysis organizations. So with our medicine, the utilization was going to be very low. It may be reasonable during that two-year TDAPA period because they would get ASP plus zero. But under the final rule that was recently released, there was not going to be an incremental increase to the base rate that dialysis organizations would get from the utilization of XPHOZAH. So there is no financial incentive for the dialysis provider to use our drug. And so there may have been potential, depending on how things might have broken during the two-year TDAPA period, that could have been helpful to us. But we knew two things. One, access would be limited because, and that's not what we want to do. We want to, again, we are somewhat, again, going back to Mike, descendants of the late great Henri Termeer. The patient should be the focus. It should always be about the patient. Keep the patient at the center of attention. And the patient was not going to be the center of attention in the TDAPA program. It It was purely financial. So we want all our patients to have as much access as possible to our drug. And that is best done by staying out of the TDAPA policy. Okay, great. And so I think there were a couple of initiatives that you had articulated to sort of forestall this January 1 moment for you. One was legislative and the other one is legal. And I know the first legal, the latter has been the case was thrown out. We were just speaking, and I think you mentioned there might be other avenues there. But we've done some checks with our Washington checks would indicate that maybe the Kidney Patient Act to delay binders going into the bundle may have less of a chance. We don't have a ton of time, obviously, between now and the end of the year. Do I have that right? Or that these avenues have perhaps been exhausted? Or do you have some other things up your sleeve here that you think you can pull out? As we mentioned and Eric mentioned, we have grit. We haven't given up yet. It's December 4th. There's still time. We have roughly 43 co-sponsors in the House to HR 5074, the Kidney Patient Act, and roughly seven co-sponsors from the Senate side, companion bills. Both are a two-year extension of the period of time that Medicare Part D reimbursement would continue till 1/1/2027. We believe that there is absolutely still an opportunity for that bill to be included in an end-of-year package. We are optimistic of that. Our team is very much involved in meeting with congressional leaders to try to make that happen. Then on the legal front, Judge Howell issued her ruling a couple of weeks ago. We have asked for reconsideration. She may or may not take that up. You're right, that is less likely of an outcome. We still, of course, have the option to appeal to a higher court should that proceed, so that is also an orderly path as well, which we still have a few weeks left, and then, of course, after that, we have the next step of our plan that you'll probably get into with Eric shortly. Yeah. And let's talk about that. So let's just make an assumption that these avenues don't pan out. And then so January 1st comes. Binders are in the bundle. There's no TDAPA exclusivity. It's, I think, fairly well known that 40% of the market is commercial pay. The other 60% is CMS reimbursed or Medicare and Medicaid. And I think you mentioned that XPHOZAH sort of is relatively consistent with that sort of ratio. So I think you guys have said essentially that you're not going to leave patients in the lurch. If they're on therapy, you'll have a relatively generous access program. Maybe just a couple of questions. I know you're not talking about guidance in this forum at this time, but I've gotten a number of questions. Does this mean that revenue just falls 60% for Q1? Is there some other sort of thing we should be thinking about in terms of the revenue trajectory if this scenario plays out? Yeah, no, we're not really in a position yet to give guidance on that. We're still learning as this progresses. So that is something that, in the appropriate time, we will certainly strive to address. It is important to note that we currently do have a generous patient assistance program and have from day one for both IBSRELA and XPHOZAH. And that will continue because it's always been important for us that if the patient wants it and they meet the criteria, we make the drug available to them. And as we progress, yes, our cost of goods sold is relatively modest. And so to the extent this becomes a patient assistance program item, it is not something that I would be overly concerned with. It goes through SG&A as a market access charge and not as a gross-to- net deduction. Yeah, and I would just add, just like the physician doesn't distinguish between Medicare and non-Medicare, neither do we. And so this decision not to apply for TDAPA really preserved access for all of those patients. So we'll continue as we move into 2025 to do just as we're doing today, as putting the nephrologist at the center of the decision-making, making sure the patient has access to XPHOZAH regardless if it's a Medicare patient or a non-Medicare patient. We need to continue with that share of voice. We need to clarify, make sure that they understand that they still can have access. I'm sure there'll be a moment of time where they'll need some proof that, in fact, when they write the prescription, yes, it will go through, and we'll handle that accordingly. We've got a great program with Ardelyx Assist to be able to offer patient support to help pull through those patients once identified, and that's what gives us confidence that we'll be able to have success when we move into 2025, and 40% of the business is fairly significant, so we're very optimistic in terms of what we'll be able to accomplish moving forward. Still a billion-dollar-plus opportunity, arguably. Justin, I'm sorry, you touched on the accounting. Let me ask a follow-up on that. So with this kind of free drug program of this size with 60% of your patients potentially qualifying for that, how would you account for that? Is that captured in COGS, or is there another line item that would fall? Yes, it would flow through our SG&A as it currently does and has for the past year as a marketing/market access expense. Because again, we believe access is the most important thing. Okay. So let's maybe, and again, this is looking around the corner a little bit, but you have to have had many discussions with private payers over commercial payers, certainly as you launched and even now. But in certain managed care markets, commercial plans will follow policies set by CMS. I think you guys signaled that maybe that's not the case here. But maybe just kind of what gives you confidence that you won't see at least some sort of more restriction on the part of commercial payers as a result of what CMS is doing here? Yeah. I mean, I think we've got a strong team with great relationships working with payers. So we're able to go out and have those conversations. Right now, it's not something that we're hearing that they are looking at. I think when you also think about the DOs and their focus on that Medicare population, to then add on the commercial or the non-Medicare segment would be additional complexity, additional volume that they would have to manage. So right now, we're not hearing anything necessarily from the commercial side or the non-Medicare side. Understanding the additional work that would be related to it from the DO side, that's what gives us confidence that moving forward, just as today, those patients in the non-Medicare segment will continue to have access to XPHOZAH. This is sort of a leading question, I guess. But I've had experience covering the renal space for a long time. And I would just say, as a group of physicians, nephrologists don't tend to be the most optimistic people in the world. But we've done recent checks. And I think the feedback has been that physicians are apoplectic about this. If you look at the guidelines that were set 20 years ago with the KDOQI guidelines and now the newer KDIGO guidelines that call for a target range of 2.5-4.5 milligrams per deciliter, achieving 2.5, that they've tried. But it's very hard now with the tools that they've got. There's a real fear, I guess, that now with this reimbursement dynamic, that things are going to be just impossible. Again, a leading question. But what is your feedback that you're hearing from physicians with respect to this? I've worried that there would be a bifurcated sort of care. I know you're providing free drug for those patients. It seems to me that you're going to have folks that still don't have access to XPHOZAH or binders for that matter. What's your view of how this market, this issue is going to evolve just from a patient care standpoint? Yeah. So again, I'm just going to continue to lean on the fact that we are trying to preserve access for those patients. Could there be some that, of course, something happens, but they're covered so that they don't have it? Sure. But we feel strongly that the vast majority of those patients would be able to have access, whether it's Medicare or it's non-Medicare. I've had the opportunity to work on some successful drugs. And those drugs, the most successful ones, they're the ones that work. They're the ones that meet an unmet need. And clearly, with this launch, three consecutive quarters, quarter over quarter growth, continuing to put up record highs each quarter tells you a few things. It tells you that the product works and there's a true unmet need. And so we feel that it's really up to us to continue that so patients have access to it. None of us would want any of our parents or siblings to be in a situation where they needed a drug like this that met an unmet need but didn't have access to it. And I think that's why we fall back on our values around being passionate. And that's what drives us every day. And that's what gives us the confidence that we'll be able to achieve that in the future. That's why we're calling on Congress and trying to get this bill extended for two years. And that's why we have such support from the patient community and other folks because it is a very unfortunate situation that we're coming to that shouldn't have to be. And there's clearly a need for access for these patients. And many of them are disadvantaged. And that's just not right. And so that's why we've been calling on Congress and have a lot of bicameral bipartisan support as well as keep getting additional co-sponsors and get different patient advocacy groups supporting this bill because, to your point, it's just not right. Okay. All right. Let's switch gears maybe to IBSRELA. It's now on a $160 million or so a year run rate. I'm not sure if this is absolutely true, but I think you beat consensus every quarter since you launched. So it's obviously been a very successful launch. Really one of the great surprises, I guess. As you know, we didn't necessarily embrace the notion. You were less supportive earlier. Early on. Or more skeptical. I believe now. But you got a solid market in second line IBS-C behind Linzess and Trulance, which are truly you've got some big dogs sort of playing, I guess, in the space here with the commercial heft behind those two drugs. Let's talk about the market sort of in general. I think I read somewhere around 50% of IBS-C patients are categorized by docs as sort of well-managed. And I think that sort of opens the door maybe for IBSRELA. Maybe just how high on the list of priorities is this in managing patients that are sort of not well-managed when you talk to physicians? You know, I'll admit, I mean, there's a lot of work to be done. But we are excited about what's in front of us. I mean, you mentioned in terms of where it's positioned second line. So we know that only about a quarter, about 25% or so patients out there are truly satisfied on their current therapy. So to your point, it really does open up a window for a product that is in a different class with a different mechanism of action with proven efficacy and proven safety for those patients out there that aren't satisfied on the initial course of therapy that the physician writes for them. You mentioned, I think, Justin, that you guys have developed a core competency here in this gastro space and that you're looking. You've got your own discovery engine and there's potentially external innovation. I think with this presence that you now have with IBSRELA, can you maybe talk about the priority of maybe bringing in another gastro asset that could complement IBSRELA? Yes, that's absolutely the next iteration of Ardelyx. So we've really been focused on the commercial success of those two products as we've just discussed. But we want to build a great company. And that means adding additional candidates to the pipeline and ultimately commercialization. So we believe we have a nice core competency both in gastrointestinal as well as renal. And so we'll be looking for complementary assets externally. I call it GI adjacent or renal adjacent. And in each stage of development, right, we want to build a pipeline. And to your point, we do have some internal candidates that we're excited about and we're doing a lot of internal research on and doing the business case analysis to make sure it makes sense. We never want to diversify. We never want to do something just to do something. It's got to be smart. It's got to be logical. It's got to be thoughtful. It's got to be cost-conscious in the sense of, is this creating value for our shareholders? So we've taken into consideration all those things. We were fortunate to add Mike Kelleher to our team in February. And he's added a really nice discipline to our approach and how we look at external candidates and really vet them to make sure they make sense. But we have a number of items in our own internal pipeline, if you will, where we're evaluating. And you can look for us to make announcements at the appropriate time. Yeah. Can I just add real quick that I would say we do have deep insights in gastroenterology and nephrology. But really what I like to say is our core competency is in commercial execution. You couldn't have any more different markets than nephrology and gastroenterology. But what you have is a solid marketing strategy, strong execution from the sales team, and a reimbursement team and Ardelyx Assist that helps pull that patient through to help get them on product. And that's what's consistent across both of those. So that's what gives us confidence to be opportunistic outside of those areas is really that core competency and commercial execution. Excellent. Maybe one more detail that I want to pivot back to XPHOZAH because I think you guys have some news or some relatively new developments in China. But just one more question maybe on IBSRELA. We have seen in some of the survey work that Spherix has done that you've got obviously the second line uptake and anticipated uptake is very robust, but that there are some docs that are trying this first line. It's like, I think, almost approaching 10%, at least in terms of the Spherix data. Any sort of sense as to whether there's some legs there in terms of actually competing with the two first line agents? That's a surprise to me that we're seeing this consistently. It has to be real if we're seeing this over and over again when these questions are asked. But any sense of first line use there? Yeah, yeah, you're right. It's something that we're definitely paying a lot more attention to. And I feel strongly that we can compete for sure against both of those products. I think what you're seeing is as physicians are increasing their use, both breadth and depth with IBSRELA, they're building more confidence. And so they're starting to use it earlier. All of that is consistent with how you see products launch kind of move into that second phase. And again, it's just another thing that we're looking at that's given us greater confidence as we move forward into 2025. Excellent. Okay. And so maybe last but not least, I know you had some development and movement in XPHOZAH in China. Can you maybe sort of talk about what's going on there with your submission? Yes, thank you for asking. Our partner Fosun filed for approval in China last year, and so we've been going through the normal orderly process with the CDE in China for the past few months. Regular correspondence, everything's progressing as you would expect. It appears that they're slightly behind in their reviews, and so I think they've had some administrative delays not unique to Ardelyx or Fosun at all, and so we were mindful of that, that we now have new information recently that look for a decision by the CDE in the first half of next year as opposed to by the end of this year, so we wanted to make sure we shared with the folks that there's new information that the decision by the regulatory authorities in China now won't happen by the end of this year. Okay, and just frame that opportunity. I mean, China obviously is a market. You mentioned core competency is commercial execution here in the States, but just frame the opportunity in China that you guys have talked about. Yes. No, we have a very good commercial agreement. We entered into years ago, milestones, royalties at all. And so there's a very large market opportunity in China for these folks. As you know, it's a developing nation in general. And so again, this drug is an excellent drug that we've already seen through the first 12 months here in the United States. So with the royalty potential we have there, it could be meaningful down the road for us for sure. Okay. Excellent. Well, I've got a lot more questions, but unfortunately, no more time. Thank you, Chris, for having us. Yeah, the great presentation. Thank you. Thank you.