Good day everyone and welcome to Ardelyx’s First Quarter 2025 Earnings. All participants will be in a listen-only mode. Now, I'd like to turn the conference over to Caitlin Lowie, Vice President of Corporate Communications and Investor Relations. Caitlin, you may begin.

Thank you. Good afternoon and welcome to our first quarter 2025 financial results call. During this call, we will refer to the press release issued earlier today, which is available on the investor section of the company's website at ardelyx.com. During this call, we will be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ significantly from those described. We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q that was filed today and can be found on our website at ardelyx.com. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our views change. Our President and CEO, Mike Raab, will begin today's call with opening remarks and an overview of the company's performance during the first quarter of 2025. Next, Chief Commercial Officer, Eric Foster, will provide an update on the performance of IBSRELA and XPHOZAH. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the first quarter ended March 31, 2025 before we open the call to questions. With that, I'll hand the call over to Mike.

Good afternoon and thank you for joining us today. We're pleased to share an outstanding start to the year at Ardelyx. We've made excellent progress across all of our priorities and continue to build significant momentum while navigating a rapidly changing and dynamic marketplace. As compared to the same period last year, we generated revenue growth of 61% totaling $74 million. This is noteworthy. Our teams are building clinical conviction for our therapies and serving more and more patients with these two important therapeutic options. We've successfully launched two products during the last three years and we're delivering on our mission. Now starting with IBSRELA. IBSRELA’s exciting growth trajectory continues. We delivered one of the highest prescription demand quarters to date during the first quarter, reinforcing our confidence in IBSRELA as a differentiated, important, and valuable treatment for patients. IBSRELA’s significant long-term potential is supported by a large and growing market and continued unmet need among patients who remain inadequately served by secretagogues. Our commercial team is effectively driving prescriber adoption by building clinical conviction among high-value targets, while our expanded field access management team is enhancing patient access and pull-through. Together, these efforts are positioning IBSRELA for sustained growth and deeper market penetration. We are on track to meet our 2025 guidance of $240 million to $250 million in net sales, and we have a clear path to achieving peak annual net sales revenue of over a billion dollars. Now turning to XPHOZAH. During the first quarter, XPHOZAH grew by 30% compared to last year, not including the one-time gross net adjustments for the return reserve release. This performance reflects the clear unmet need that exists for patients, the growing role that XPHOZAH is playing in helping patients achieve and maintain target phosphorus levels, and the remarkable momentum our team built in 2024. It is important to recognize that with the loss of Medicare Part D coverage for phosphate-lowering therapies, the dialysis market is undergoing significant disruption, and it is causing increased frustration among both nephrologists and patients. Our decisions around XPHOZAH remain firmly grounded in a commitment to patient care. Amid this uncertainty, we're encouraged by early signals. Patients across both Medicare and non-Medicare segments are successfully accessing the therapy, and real-time feedback from the field reinforces XPHOZAH’s clinical value. As the environment remains fluid, we are not yet providing formal revenue guidance at this time. Instead, we are closely monitoring uptake and market dynamics, and we will provide further updates as the landscape continues to evolve. Across the board, Ardelyx continues to execute with resolve, discipline, and agility, and we're making progress in our strategic priorities, driving strong commercial execution for IBSRELA, navigating the access complexities, and generating important commercial momentum with XPHOZAH, building a pipeline to unlock long-term growth, and continually delivering strong financial performance. Our high-performing team, differentiated products, and commitment to patient-centric innovation position us to lead and grow in a rapidly evolving healthcare environment, and we remain steadfast as we build long-term value for our shareholders. Thank you for your continued support and confidence in Ardelyx, and I will now hand it over to Eric to share his perspectives on our commercial performance during the first quarter.

Thanks Mike, and it's great to be with you all again. Q1 was another great quarter for both products. IBSRELA and XPHOZAH delivered meaningful year-over-year growth. Consistent with prior Q1s, we saw the IBSC market contract, and as you know, the hyperphosphatemia market was impacted by the elimination of Medicare Part D coverage for phosphate-lowering therapies. Despite these headwinds, we saw strong prescription demand for IBSRELA and demonstrated that both Medicare and non-Medicare patients are able to access XPHOZAH as we continue to meet the unmet need in the market. The team is focused on execution and building on our Q1 momentum as we enter an important second quarter in a position of strength. Let me start with IBSRELA. IBSRELA grew 57% over last year. This is incredible growth as we enter our third full year post-approval. We saw increases across key demand indicators, including new and total writers and new and refill prescriptions. As I mentioned before, the IBSC market historically contracts during the first quarter, and we saw clear evidence of it in Q1, especially early on. Despite that contraction, IBSRELA demonstrated strong prescription demand consistent with Q4 and exited the quarter with very strong momentum. This is further evidence of the confidence that healthcare providers have in IBSRELA and the value this medicine can bring to patients. As we look ahead, we remain focused on making progress against our strategic imperatives to drive growth and help more patients with IBSC, which include raising awareness and favorable perception of IBSRELA, expanding target healthcare providers' view of potential IBSRELA patients, positioning IBSRELA as the first action for appropriate patients who are not getting adequate relief or are not satisfied on a secretagogue, and encouraging healthcare providers to send prescriptions to one of our specialty pharmacy partners or ArdelyxAssist. These strategic imperatives are allowing us to create opportunities across all aspects of the physician and patient journey to improve healthcare provider perception, drive consideration, and support prescription pull-through. Our expanded field-based teams and our omnichannel marketing initiatives are focused on these areas, and we continue to see improvement. IBSRELA is an important treatment option for patients with IBSC, and we remain confident in our path to greater than $1 billion peak year net sales revenue. Now on to XPHOZAH. XPHOZAH had another very strong performance, delivering 30% revenue growth compared to last year when you exclude the returns reserve release. This demonstrates that XPHOZAH continues to be an important medicine to help patients achieve and maintain target phosphorus levels, despite the turmoil and disruption in the market. It also gives us confidence that XPHOZAH’s strategy is working. Most importantly, the operational plan has allowed patient access to continue. We're driving a clear message to healthcare providers that is resonating: prescribe as you always have, based on the patient need, and we will support access through our patient services programs. As we look at XPHOZAH's performance during the quarter, there were several positive indicators that give us confidence as we move forward. We saw new writers prescribing during the quarter, as well as both new and refill prescriptions continue. In addition, our internal market research indicates that the vast majority of surveyed nephrologists recognize they are the decision-makers for XPHOZAH prescriptions and they continue to believe that at least 30% of the patients are candidates for XPHOZAH. To maintain the momentum that the team has established, we must remain focused on the factors that influence our ability to drive demand. There is a high unmet need among dialysis patients for tools to achieve and maintain target phosphorus levels. Physician satisfaction with XPHOZAH remains high. Access to XPHOZAH has been protected. And lastly, we have a strong share of voice in the market. The commercial team and all of team Ardelyx have been steadfast in our commitment to bring these first-in-class medicines to patients who continue to struggle with their conditions. We have a winning position in two markets with high unmet need and a high performing team that consistently drives results, and we are eager to achieve our potential as quickly as we can. We are focused on executing our plan and maintaining the growth momentum for the remainder of the year. I will now turn it over to Justin.

Thank you, Eric. We were very pleased with the financial performance we reported earlier today, which demonstrated significant year-over-year revenue growth, careful management of expenses to support continued commercial excellence, and a strong cash position to continue building the business. We had total revenues of $74.1 million in the first quarter of 2025, an increase of 61% compared to the $46 million we reported last year. The growth was driven primarily by strong performances and significant increases in net product sales revenue from both of our commercial products in the first quarter of 2025 compared to the same period of 2024. During the first quarter of 2025, we recorded IBSRELA net sales revenue of $44.4 million, an increase of 57% over the same period of last year. Our growth was driven by strong patient demand and the continued focus on commercial execution from clinical consideration to prescription pull-through. As we have consistently shared with you in the past, our net sales were impacted during the quarter due to normal Q1 market dynamics. In line with our expectations, the gross net deduction for IBSRELA for the quarter was 34.8%, and as we've experienced, we expect this to improve throughout the course of the year. We expect continued growth for IBSRELA and we reaffirm our 2025 guidance of $240 million to $250 million in net product sales revenue. We also recorded $23.4 million in net product sales revenue of XPHOZAH in the first quarter of 2025, an increase of approximately 55% compared to $15.2 million in the first quarter of last year. As you saw in our press release, XPHOZAH net sales revenue includes a one-time $3.8 million release of our returns reserve. Excluding this returns reserve release, our year-over-year growth for XPHOZAH was 30%. Our returns reserve considers our returns policy in the passage of time since launch. When coupled with zero product returns to date in our open return window and the very low number of bottles in our downstream distribution channel, it was clear that a returns reserve is unnecessary. As a result, our gross net deduction for XPHOZAH during the first quarter was approximately 18%. Excluding the impact of this release, it was approximately 32%. In addition to product revenue, we earned a $5 million milestone from our partner in China following the approval of Tenapanor for hyperphosphatemia. We received payment from Fosun Pharma in April. We also recorded $1 million in non-cash royalty revenue during the first quarter of 2025 compared to $370,000 in the same period last year. Research and development expenses were $14.9 million for the first quarter of 2025, compared to $10.6 million for the same quarter of the prior year. The increase in R&D expenses reflects increased engagement with the scientific and medical communities. Selling general and administrative expenses for the quarter were in line with our expectations at $83.2 million compared to $53 million that were reported for the same period in the prior year. The increase was related to commercial activities for IBSRELA and XPHOZAH, including the IBSRELA salesforce expansion, as well as growth of the overall corporate infrastructure to support our strategy. In the first quarter of 2025, we also had $12.1 million in non-cash stock compensation expense and $2.1 million in non-cash interest expense. We had a net loss of approximately $41.1 million or $0.17 per share in the first quarter compared to a net loss of $26.5 million or $0.11 per share in the same period of last year. As of March 31, 2025, our total cash, cash equivalent and short-term investments were $214 million. The first quarter demonstrated strong demand for IBSRELA and clear evidence that the XPHOZAH strategy is working. We remain confident that there is a significant opportunity for both of our medicines that we are on track to achieving our peak sales expectations. More than $1 billion for IBSRELA and $750 million for XPHOZAH. We are building a great company and focused on delivering shareholder value. With that, I'll hand it back to Mike.

Thanks, Justin. It's been quite an eventful first quarter and through all of it, we executed and created opportunities that will continue to be our focus moving forward. I will now open the call for questions. Operator?

Our first question comes from Louise Chen of Scotiabank.

Congratulations on all the progress this quarter. I wanted to ask you two questions here. First, for the IBSC market, do you expect this to improve as you go through the second quarter and beyond versus the contraction that you historically see in the first quarter and how should we see that play out? And then secondly, could you explain in more detail the return reserve and how that impacts the sales and what that could look like going forward?

Sure, let me ask Justin to start with the second question first.

Thanks, Louise. Yes, so as part of our gross net, we have a returns reserve, and our returns reserve again is contemplated from the beginning of launch. When you couple our progress over the last five or six quarters where we've had zero returns and very limited bottles in our downstream distribution, it was no longer appropriate to carry this reserve on our balance sheet. So, we will no longer be doing this prospectively, and this, of course, would have modest improvement to our gross to net prospectively.

Eric?

Yeah, thanks, Louise, for the question. With regard to the IBSC market improving as we go through the year, the short answer to that is yes. The IBSC market in the first quarter, we know traditionally contracts, and that's exactly what we saw early on in Q1. We continue to remain very optimistic given that we had our highest prescription demand quarter in Q4 and we were able to see that consistent in Q1. And certainly, we're able to finish the quarter with strong momentum that gives us a lot of confidence as we move into Q2 and the rest of the year and we'll continue to see that improve.

Thank you.

Thanks Louise.

Our next question comes from Ryan Deschner of Raymond James.

Hi, thanks for the question. Just wanted to ask a little bit more about the 1Q contraction. What are you attributing the level of overall contraction in 1Q? Is it looking different from prior 1Q situation? And then I have a follow-up.

Sure, thanks for the question, Ryan. I think just for some context, the market has consistently contracted in their first two years on the market. Given the volume that we were generating, probably not as much of an impact, but as this business grows, as Eric, I'll ask him to address it, it's something that we are expecting as we move forward. I think if you compare us to others within that market basket, I'm pleased with the performance that we saw in IBSRELA. Eric?

Yeah, I would just add that as we continue to grow volume, we're starting to see a bit of a response similar to that of the market in the first quarter, but it's still a very healthy market continuing to grow double-digit growth as it has over the past few years. And as I mentioned just a minute ago, we expect that to continue to grow in 2025 for the rest of the year.

Got it and then what are you targeting for your long-term growth to net if you're disclosing a level for XPHOZAH at steady state, and also do you have any color in China now that it's approved?

Yeah, so China first, once we get more perspective from our partner, we can share that. So, probably not much to talk about there. Justin, if you could address the gross net?

Sure, it's still early because we're in the new treatment paradigm, if you will, the coverage mix where it's changing in 2025 compared to 2024. So, we're not really fully there yet. I would say we had 32% irrespective of the gross to net change we made for the returns reserve in Q1.

I think it's fair to say, Ryan, and Justin correct me if I'm wrong, that generally our guidance for both is 30% plus or minus 5 is likely to hold true continually going forward.

It's a great place to start modeling.

That's very helpful. Thank you very much.

Thanks, Ryan.

Our next question comes from Dennis Ding of Jeffries.

Hi, thanks for taking our questions. Two for me. On IBSRELA, how do you guys reconcile what's being reported through IMS and the $44 million in revenue that you guys reported? Because, based on scripts and I think through some reasonable assumptions, I think people were expecting around $52 million, so the $44 million was quite a surprise to us. And then, question number two is on the CMS litigation on XPHOZAH. When do you expect the decision on the appeal? And I guess hypothetically, if there were a positive decision and XPHOZAH was given back Part D, how quickly can things be restored back to 2024 levels in terms of the underlying structural logistics at the DOC?

Well, I'll address the last question first. I mean, it's probably not healthy to get into hypotheticals just given everything that we're seeing going on in Washington. All of the briefs that need to be filed are filed, and we're just waiting for the courts to set a date and we will navigate through that. As we learn more, we will certainly bring it to your attention. I'll ask Eric to talk a little bit about your question around scripts, but remember, as we've talked about this over the years, that there are going to be fluctuations in scripts, which is why what we've said consistently is you need to hold us to account for the guidance that we give you. And as you heard all of us say, we are confident that 240 to 250 and the perturbations in the first quarter are part of the reason that we encourage you to look at it as such. Eric, any thoughts?

Yeah, thanks, Dennis. Good question. As we think about demand, we were very pleased with what we saw in Q1. As I noted, consistent with what we saw in Q4, which was our highest demand quarter to date. Certainly, when you look at net sales, it can be impacted by market dynamics. When we think about Q1, we typically see things like the IBSC market contract. We've got prior authorization renewals, insurance coverage resets, wholesaler buying patterns, and higher patient co-pays, and all that needs to be taken into consideration. But what gives us confidence is we've seen that in the past. We also see that it normalizes, and we feel like we really ended the quarter with strong momentum and certainly feel very confident as we go into Q2.

And Dennis, I think what's important about that strong momentum is Q1 was our second highest generation of demand to date, right? So, what Eric just described certainly is, I'm sure from the perspective that you're bringing, frustrating given the numbers that you thought, but we're extremely happy with the performance that we saw, particularly since this is the second highest demand, and we were not impacted by the contraction the way other products were in the IBSC market basket.

Got it, thanks.

Thanks, Dennis.

Our next question comes from Laura Chico from Wedbush Securities.

Thank you for taking our question. This is Dylan on behalf of Laura Chico. I was curious about the metrics you are monitoring to evaluate the impact of the newly expanded IBSRELA sales force and what gives you confidence that you are on track to meet the peak revenue expectations.

Sure, first of all, I think the caliber of the people that we've hired and what we're seeing already coming out of the fourth quarter fully on board and trained gives us that confidence. This was the second largest quarter of demand generation that we've seen since launch. That is part of the confidence I have in it. In the midst of that market contraction, we contracted less than the others, which also gives me confidence. The incredible unmet need that's out there and the better access we have with the larger sales organization all come together. Eric, do you have any other thoughts?

Yeah, for me, I mean, what I think about is, it is really three things. Are we seeing an increase in activity? Are we seeing an increase in writers, whether it be total writers or new writers? And then are we seeing that lead to new and refill prescriptions? And as it relates to year-over-year, we certainly see significant increase in activity. We see an increase in new and total writers, and then we also see an increase in the new and the refill prescriptions. As Mike mentioned, Q1 is the second highest demand, prescription demand quarter to date. And there we saw an increase in total writers as well as new and refill prescriptions looked really good coming off of what Mike said was our highest demand quarter in Q4. So, those are some of the basic metrics that we look at to make sure that we're getting the activity that we need, that's generating new and total writers that's leading to new and refill prescriptions, so that we can help the higher number of patients out there that need this treatment for their IBSC.

Thank you.

Thanks, Dylan.

Our next question comes from Joseph Thome of TD Cowen.

Hi there, good afternoon. Thank you for taking our questions. Maybe the first one, can you comment a little bit on the demand specifically in the commercial channel, and how that changed from Q4 to Q1 for XPHOZAH just to kind of get an idea of growth in that segment; and then a question on the financials, when we look at the R&D and SG&A spend for this quarter, should we use this as sort of the new base going forward? And maybe relatedly, how much wiggle room do you have in the spend for XPHOZAH to make sure that business stays profitable going forward depending on what we see this year?

Sure, let me ask Justin to address the second part of your question first.

Great, thanks Joe. Yes, we had a modest increase in our SG&A in Q1 compared to Q4, so you might have seen an increase from $76 million to $83 million, and we expect that will rise over the course of 2025 to around $90 million by the end of the year, making sure we have all the appropriate team members to support the commercial team and to your point, make sure XPHOZAH and all the patient access everything else is available through either our patient assistance program, our field managers and everything in between. So, we feel like that is in good shape and so modest increase over the next few quarters. From an R&D perspective, we were approximately $15 million in the first quarter, and we expect modest growth in that over the course of the year. So, we're in great shape; again, we finished the quarter with $214 million, and we're in good shape from a financial position.

And Joe, just to clarify, your question is more than just commercial, it's the non-Medicare segment, right?

Correct, yeah.

Okay. Eric, could you address that?

Yeah, thanks, Joe. What we saw in Q1 was we saw that Medicare had about a weighted average of around 13% of the total payer mix. We think about that, we saw that it was primarily in the first few weeks. Unfortunately, these patients had the benefit of a one-time transitional fill through CMS and we saw that take place. And like I said, it was primarily in the first few weeks. But what we saw as the quarter continued to move, the rest of the mix was really predominantly through the commercial and the Medicaid side, which as you know is the non-Medicare mix. So, we were able to see good momentum there as the quarter continued and feel really good about where things ended at the end of Q1, and that's given us continued confidence as we move forward, and really focusing on being able to allow all patients, regardless of whether it's Medicare or non-Medicare, be able to have access moving forward.

Yeah, I guess I just want to follow up to the financial question is it's not that we're necessarily looking for wiggle room. I think we have incredible confidence on the trajectory that we're on with XPHOZAH in the way that we've approached the market. So, it's not that we're looking for wiggle room. I think we're on track with what we anticipated, which is why we reaffirmed the $750 million peak, and the hope is and expectation that in the not too distant future we can give you more perspectives on what our views are for this year.

Great, thank you very much, very helpful.

Thanks, Joe.

Our next question comes from Roanna Ruiz of Leerink Partners.

Hey, good afternoon everyone. Follow up about XPHOZAH. I was curious, do you have any updates on how the patient assistance program is operating right now and some of your plans to keep going forward into Q2 and Q3? And the second part of it is, I was also curious of the last question thinking about commercial and non-Medicare, how are those trends possibly tracking into exiting 1Q and thinking about 2Q and 3Q?

Sure, let me ask Eric to address this for you.

Thank you. Regarding the patient assistance program, we are very pleased with how Ardelyx is supporting Medicare patients. We noticed that patients using XPHOZAH through Medicare Part D in the fourth quarter were able to continue their access in the first quarter thanks to our patient assistance program. We are happy to assist these patients and the new ones that began treatment in the first quarter. Our commitment is long-term; ensuring access for patients in need is our top priority. We are not making decisions based on quarterly results but are focused on ensuring that all patients, whether they have Medicare or not, have coverage for XPHOZAH. Concerning our commercial business, we are also satisfied with what we are seeing in the non-Medicare segment. As mentioned, the majority of the transitional fills for Medicare occurred in the first few weeks, but that trend has since diminished, so we are not including it in our forecasts. Our main focus is on driving growth in the non-Medicare sector, especially through commercial Medicaid and the VA business. We saw a notable increase in the latter half of the first quarter, which gives us confidence as we progress through the rest of the year.

I just want to add a few thoughts on that, Ron. Our confidence grew starting in January, when there were many uncertainties about how things would unfold. By March, we observed the challenges they faced, notably getting their binders through the decision makers. Some of the binders they had been working on for a long time were no longer available. Ultimately, we chose to collaborate with the nephrologists, who were previously central to the decision-making process, despite the ongoing turmoil. I'm very pleased with how our team has assisted them in navigating these challenges, and the effectiveness of the ArdelyxAssist team and their program is beginning to show positive results.

Got it, thanks for the help.

Thank you.

Our next question comes from Julian Harrison from BTIG.

Hi, thank you for taking my questions. When you look at high volume IBSC prescribers, are you left with the impression that they generally know who the best candidates are for IBSRELA? And I ask this because I'm aware of some recent survey data you guys have suggesting a disconnect between prescribers and patients on how large the unmet need is and I'm also just wondering how you expect maybe the gap to narrow there going forward.

Yeah, just one quick comment, I'll ask Eric to address it. A disconnect between prescriber and patients is probably a pretty traditional phenomenon across many therapeutic areas. And to me at least with what I see, the significant untapped potential that's out there is remarkable. Don't forget that all of our clinical work was first-line therapy, and the fact that a new mechanism like this, given payer dynamics is what forces you into making the decision we made. We didn't want to negotiate with payers that we would be second line is what gets us to where we are. The dissatisfaction when you talk to patients with what they have with GCC agonists is kind of hard when a physician doesn't yet understand this new mechanism and what it is that we can provide that they may see a disconnect between the patients thinking, but that's the work and why we expanded the field and the yields that we're seeing from that effort. Eric?

There are certainly many opportunities available. We recognize the disconnect that exists and take it very seriously as our responsibility to bridge the gap between physicians and patients. Physicians do identify who these patients are. When we speak with them, they mention patients diagnosed with IBSC who are currently on secretagogue therapy but are not satisfied or not experiencing sufficient relief. Our goal is to encourage physicians to act with urgency. They have been prescribing secretagogues for a decade, so we need to continue working on changing these habits. It's about helping them identify the appropriate patients. We feel that we are making progress, but it’s crucial for them to act quickly so they can be the first choice when a patient is not satisfied or not receiving adequate relief. We are aware that a significant number of patients fit this description, as only about a third are satisfied. This leaves many patients currently diagnosed and undergoing treatment who are not satisfied and not achieving adequate relief, and we are seeing IBSRELA being utilized as a second line for those patients.

Our next question comes from Aydin Huseynov from Ladenburg.

Hi, good afternoon, everyone. Congratulations with this quarter. I got a couple of questions. Appreciate XPHOZAH’s long-term guidance confirmation of $750 million. Could you provide some dynamic of sort of how you plan to get there, sort of ramp up curve and if possible, any 2025 sort of soft guidance sort of hints? And does the long-term guidance not include Medicare and in case you are able to sort of include Medicare further on, how would that actually affect the upside for XPHOZAH sales, big sales?

Sure, let me address that for you. We assume Medicare is not part of the mix in terms of paying for XPHOZAH for those patients. That's roughly 60% of the dialysis population; non-Medicare is primarily Medicaid and commercial. The comments from both Eric and I that what we see already in the first quarter makes us feel confident that that is going to be what we are able to confidently get to $750 million. As we said last year as we were entering this year and reaffirmed in my opening comments, it's too early for us to be giving you guidance as to what 2025 is going to look like. Once we have confidence and I believe it will happen in the not too distant future, we will provide you some perspective as to what we think 2025 will turn out to be.

Thank you. Appreciate that. One follow-on question. How much of the decision-making by nephrologists may affect the insurance coverage, and have you seen any pushback from payers so far for XPHOZAH given your sort of ongoing negotiations with CMS?

Sure, payer and CMS are probably not correlated; two very separate things. The nephrologist and the healthcare providers are extremely important as it relates to getting prior authorizations through. Eric, other thoughts?

Yeah, I would just say, right now we're really not seeing any pushback on the commercial side. And it's good to see that the nephrologist still has the ownership and really is at the decision-making center. For those patients that need it, if they have commercial coverage, then certainly, the physician can write for it, and we've got confidence that the patient can get it on the commercial side.

And our ArdelyxAssist program is extremely helpful in navigating that process.

All right, thanks so much.

Thank you.

Our next question comes from Allison Bratzel from Piper Sandler.

Hi, thanks for taking my question. This is Ashley asking on behalf of Allison Bratzel. I have two questions. First, regarding XPHOZAH, we haven't heard much about the Kidney Patient Act. It seems like this is turning into a sort of call option; do you have any updates on that? And my second question is about potentially bringing in a GI or renal-related external asset. You've previously indicated interest in doing so. Is that still the plan? When might we hear more about this? Are you primarily focused on the ongoing launches of your commercial products? Any information on that would be really helpful.

Thank you for your questions. Regarding asset development, we have recently assembled a team led by Mike Kelleher to focus on corporate development and the licensing acquisition of assets, particularly in renal and GI areas, as well as related fields where appropriate. This work is ongoing, and we are pleased with the progress we're making. As we develop our internal programs or acquire external assets, we will announce any significant updates. This initiative is crucial for our goal of growing the enterprise. Concerning the Kidney Patient Act, you accurately described it as a free call option. At the end of last year, we indicated that you should hold us accountable for the $750 million, which is based on 40% of dialysis patients, roughly translating to a total addressable market of around 220,000. So, considering it as a free call option is spot on.

Great. Thank you so much.

Thank you.

Our next question comes from Prakhar Agarwal from Cantor Fitzgerald.

Hi, this is someone stepping in for Prakhar. I’m looking to understand the strategy for increasing the use of XPHOZAH in non-Medicare channels and when we might see a significant increase in usage in those areas.

I'm sorry, I couldn't hear the entire question. Expanding XPHOZAH into Medicare, did you say?

Non-Medicare channels. What is the strategy around expanding XPHOZAH uptake in non-Medicare channels?

Yeah, so with non-Medicare, that's going to be Medicaid, as I said, and commercial are the two main components of non-Medicare, and that is 40% of the patient population. They are seen by nephrologists, which are the people that we call on. And one of the important aspects of the way that we do it is we don't tell the nephrologist to discern who's Medicare and non-Medicare. We have a close distribution system that goes through our ArdelyxAssist program so that we adjudicate those who are Medicare and those who aren't Medicare, and those who are Medicare transition into our patient assistance program, and if they qualify, they get free drug. If they aren't Medicare, then we work with them through the system if there's prior authorization to get their prescriptions filled.

That concludes our question-and-answer session. Now, I'll turn the call over to our host for any additional or closing remarks.

Thank you all for joining us this afternoon, and a special shout out goes to team Ardelyx, who I know is listening. Your hard work is invaluable in bringing our essential medicine to our patients. Thanks also to our shareholders. We are building a great company and focused on doing what is right for patients and creating long-term value. With that, we can conclude the call. Thank you, operator.

That concludes today's meeting. Thank you for joining and have a pleasant day.