Ardelyx at Jefferies London Healthcare: Strategic Growth and Challenges

On Wednesday, 19 November 2025, Ardelyx (NASDAQ:ARDX) presented at the Jefferies London Healthcare Conference 2025, showcasing its strategic growth and challenges. The company highlighted strong performance in its IBSRELA and XPHOZAH franchises, while also addressing regulatory and market hurdles. Ardelyx is optimistic about achieving profitability by 2026.

Key Takeaways

• Ardelyx increased guidance for IBSRELA to $270-275 million for the year, aiming for a billion-dollar opportunity.
• XPHOZAH faces challenges due to the TDAPA period but expects growth post-2026.
• The company ended Q3 with $242 million in cash and is nearing cash flow positivity.
• Ardelyx plans to file an IND for a new molecule, 531, next year.
• The company is actively seeking in-licensing opportunities to expand its pipeline.

Financial Results

IBSRELA:

• Guidance increased to $270-275 million for the current year.
• Aims for $1 billion in revenue, requiring about 200,000 patients.
• Growth is expected to be non-linear due to marketing efforts.

XPHOZAH:

• Contributes positively to the product P&L despite TDAPA-related challenges.
• Long-term sales target of $750 million by reaching 60,000 patients at $12,500 per patient annually.

Overall Financials:

• Achieved nearly $1 million positive cash flow before stock-based compensation in Q3.
• Expects to be profitable by 2026.

Operational Updates

IBSRELA:

• Expanded sales force, covering 50% of the TRX market.
• Improved approval and resubmission rates with an expanded field access manager team.
• Patients using Ardelyx Assist report higher satisfaction.

XPHOZAH:

• Increasing patient access, including through Medicare assistance programs.

Pipeline:

• Development of 531, a potent NHE3 inhibitor, with an IND filing planned for next year.

Future Outlook

IBSRELA:

• Patent runway of approximately seven years.
• 531 considered for lifecycle management.

XPHOZAH:

• Expects growth post-TDAPA period, aiming for $750 million in peak sales.

Overall:

• Aims for profitability by 2026, generating cash for pipeline development.
• Pursuing in-licensing opportunities in GI/renal or adjacent areas.

Q&A Highlights

IBSRELA:

• Non-prescription often due to lack of awareness among doctors.

XPHOZAH:

• TDAPA incentivizes dialysis centers to use binders more frequently.

Pipeline:

• IND filing for 531 expected next year, with indications still being explored.

Financials:

• Positive cash flow anticipated by 2026, with continued growth expected.

Corporate Development:

• Exploring in-licensing opportunities to bolster the pipeline.

For more details, please refer to the full transcript below.

Full transcript - Jefferies London Healthcare Conference 2025:

Dennis Ding, Biotech Research Analyst, Jefferies: Hello, good afternoon. Welcome to the Jefferies London Healthcare Conference. My name is Dennis Ding, biotech research analyst here at Jefferies. I have the wonderful pleasure of having Ardelyx here with me. We have CEO Mike Raab, as well as Chief Commercial Officer Eric Foster here. Welcome.

Mike Raab, CEO, Ardelyx: Thank you.

Eric Foster, Chief Commercial Officer, Ardelyx: Thank you, Dennis.

Dennis Ding, Biotech Research Analyst, Jefferies: Maybe to kick things off, why don't you give a little bit of background of Ardelyx and some of the franchises that you have going on that's commercial, and just talk about the progress that you made this year and perhaps even some of the outlook into 2026.

Mike Raab, CEO, Ardelyx: Sure. Dennis, thank you, and to you and Jefferies for inviting us. It's been a wonderful conference so far. We founded this company in 2007, and it was with the simple idea of developing small molecule drugs that worked within the lumen of the GI. It had not been an area that had really been focused on in drugging and creating molecules like we have. As we began the development of an NHE3 inhibitor, we learned not only was it a benefit for constipation, but we also had a benefit that we demonstrated in pain, which is ultimately what you needed to do to get an indication in IBS-C. We also then learned, and this will address some of the things that we talked about in last earnings call around a new molecule that we're working on, is that we also block phosphorus.

There was really interesting biology to explore when we started the NHE3 inhibition program of what we could do with those molecules. What we progressed on then after that was getting approved in IBS-C, which is IBSRELA, and then in hyperphosphatemia, XPHOZAH. Those are the two franchises. As we described at earnings, this has been a phenomenal year where every quarter we, and Eric and his team, have provided growth and demand across all areas in both IBSRELA and XPHOZAH. For IBSRELA particularly, we finished the third quarter, we increased our guidance to $270,000,000-$275,000,000, and really feel very good about the trajectory that we're on into 2026 and beyond. Re-emphasized the billion-dollar opportunity that we see IBSRELA becoming and the number of patients that we're providing the benefit for for IBS-C.

Eric will address some more of that in terms of how we differentiate versus the secretagogues that are on the market. We also saw that XPHOZAH, it goes through this tumultuous period of the TDAPA period. There are more patients that are getting access to XPHOZAH today than ever. The confusion, the issues around Medicare are what people are having a hard time wrapping their arms around. If you look at the growth of XPHOZAH, it is a contributor on a product P&L basis, so it is not a drag on the enterprise. It is helping people and will continue to grow. Eric will address some of the issues there as well.

Dennis Ding, Biotech Research Analyst, Jefferies: Great. Why don't we start off with IBSRELA because that has seen tremendous growth this year, and you guys have been raised a few times in terms of your 2025 guidance. What is really driving that growth this year, and could it accelerate in 2026?

Mike Raab, CEO, Ardelyx: Sure. Eric.

Eric Foster, Chief Commercial Officer, Ardelyx: Yeah. Thanks, Dennis. Great to be here and great to be with everybody today. As Mike said, we're very pleased so far with our success this year. We expanded the sales force last year at the fourth quarter. What we were trying to do there is really increase the reach of our team. We cover approximately 50% of all the TRX market that's out there. That's around 14,000 or so physicians with our team. The team really is hitting their stride. We're now about four quarters into that. What we've seen this year is we've continued to generate consistent quarter-over-quarter growth in demand. First strategy is really getting the sales team out there, making sure that they're in front of the right customers, identifying patients, driving clinical conviction.

At the same time, we also need to make sure that we're pulling through those patients. If a physician or an APP decides that a patient should have IBSRELA, we want to make sure that that patient has access to it. We committed to our field access manager team, and we expanded them in the second quarter. What we've seen is, again, quarter-over-quarter improvement in approval rates and resubmission rates. What that means is that more patients are able to benefit from IBSRELA when the physician finds that that's the right product for them. We know with Linzess and Trulance, those are secretagogues. About 75, a little bit more than that, 77% of the patients that are out there, our own research tells us, they continue to have symptoms. They need something different.

IBSRELA is in a different class of therapy and provides a different option for those patients. We feel like we've got a winnable and sustainable position. We're driving the top of the funnel. Our access manager team are pulling those patients through. We're seeing all-time highs across all those key demand indicators in Q3.

Mike Raab, CEO, Ardelyx: I think one thing that Eric did not mention, which is really important that was discussed at the American College of Gastroenterology, is that 77% that are not satisfied on the secretagogues. You ask a similar question of IBSRELA patients, 80% of whom are satisfied with the benefit that they are getting compared to what they had with secretagogues. It is an incredible contrast between the two. I think that is what is driving off a lot of the success of your industry.

Eric Foster, Chief Commercial Officer, Ardelyx: The poster that Mike is citing was actually presented at the American College of Gastroenterology just about three weeks ago. I'm really proud of that data.

Dennis Ding, Biotech Research Analyst, Jefferies: Okay. There seems to be, at least from a patient perspective, a lot of people are happy with the benefits that IBSRELA can provide. It does seem like there is a very big market. Remind us again, how big do you think is the market? What can you do to actually penetrate that and maybe even accelerate that over the next few years?

Eric Foster, Chief Commercial Officer, Ardelyx: It is a sizable market, very well established. Last year, more than 6 million prescriptions were written for IBS-C in the total market. It has continued to grow, double-digit growth over the past three years. To your point, very sizable patient population out there that is looking for something different. For us, it is really that story around driving top of the funnel, clinical conviction with HCPs, and pulling those patients through. We also have a hub, Ardelyx Assist. What they do is they help when the patient, when the prescription comes in, it goes through Ardelyx Assist, and they are able to fill that through a specialty pharmacy. We know in this market, these patients, they have seen five, six, seven physicians. When they go through our own internal hub, they get additional touches.

We know that when patients do that, they have a better experience and better satisfaction with the product.

Dennis Ding, Biotech Research Analyst, Jefferies: Okay. If we look at consensus numbers for IBSRELA in 2026, and even now too, whenever the patents expire, maybe it's around 2032, 2033 timeframe, it seems like a fairly linear trajectory from where we are now, which is around $270,000,000-$275,000,000 to $1 billion. What do you think of that, and where do you think consensus may be wrong?

Mike Raab, CEO, Ardelyx: I mean, consensus is hopefully driven by some thoughtful modeling that has been done. I think for us, what we look at is to get to $1 billion, right? You think about the 6 million individuals that are on the GCC agonist. As we've described a number of times, for us to get to the $1 billion, it's about 200,000 patients, maybe less. Given the structure of what we do and the support that we provide, it's hard to imagine, given the benefit that we described earlier, that we're not going to see of the 77% of patients that aren't satisfied with the GCC agonist, that a large number of them would be able to benefit from IBSRELA. How do we do that is the way that Eric just described. It's the rate at which we grow, right? It's what we've talked about numerous times.

Is it linear? Are there going to be things that we do on the marketing side, the team, the fans, as Eric has described? Those are important catalysts as we move ahead. It takes time for the expansion that started that we finalized expansion just about a year ago. It takes three or four quarters for the full benefit of that investment to bear fruit. I think you're going to continue to see the kind of growth that we have. I think some of the views that consensus has is it's a tapering of growth because of the just general views that the bigger base means a tapering of percentage.

That may be true, but it also may be that we continue to grow at the pace that you see, given the number of patients that are unsatisfied with current therapies and the benefit that clearly we see IBSRELA providing.

Eric Foster, Chief Commercial Officer, Ardelyx: Yeah. I would just also add, we have a runway of about seven-ish or so years until patent expiration. There is really not another competitor that is on the market. We feel really good about our position. We have a great product out there that we know is driving patient satisfaction as a clear, unique, differentiated position and really has a very long runway to be able to achieve those numbers you were just talking about.

Dennis Ding, Biotech Research Analyst, Jefferies: What's been some of the feedback from patients who are not on IBSRELA or maybe even doctors who may not be prescribing it? Is it just due to awareness, or is there anything specific with the product that they're just not familiar with?

Eric Foster, Chief Commercial Officer, Ardelyx: Yeah. You know, that's a really good question. I think it's an important one too. We're just now in our third full year of being into the market. Remember I said we're covering 50% of the TRXs that are out there in the market. That's about 14,000 physicians. The other 50% of the market, it's 180,000 physicians. For us, it's really getting the word out there, driving awareness. We take a very targeted approach, very purposeful approach, but we need to continue driving awareness because we know that when physicians become aware of IBSRELA, they see the clear need because they're used to the experience that they're getting with Linzess and Trulance. They recognize the need. They recognize the product profile and the need for something different.

What we're able to see is, again, this year, quarter over quarter, increased breadth, so number of new writers, and increased depth. Once the physician does start writing, we know that they continue to write more.

Mike Raab, CEO, Ardelyx: The marketing programs that are communicating more broadly, where patients are given the information where they can go and ask for IBSRELA by name, we know that when that happens, the likelihood of that being granted by the physician is about 80% of the time. The patient engagement involvement in the decision-making is really important.

Dennis Ding, Biotech Research Analyst, Jefferies: You just finished, and we're, I guess, about one year into your sales force expansion. Should we expect continued full productivity from that expansion in 2026?

Eric Foster, Chief Commercial Officer, Ardelyx: Yeah, I think so. I mean, what they've done is they've really raised the bar in 2025. We're seeing increased activity is driving increased amount of riders, is driving increased prescriptions. I mentioned the 14,000. For us, we're continuing to look at ways we can optimize reach and frequency to those customers. There might be some optimization, if you will, around the edges, but certainly don't see any kind of large-scale expansion in the near future. I feel really confident about the target population of physicians that we have out there, what we're able to achieve right now with the expansion. Like I said, we might optimize some things, but we're just constantly looking at what's the right number of people to impact that core target of HCPs that we know is driving half the market.

Mike Raab, CEO, Ardelyx: I think what we talked about before too is in the second quarter of this year, we added about 20 field access managers. They're focused on the bottom of the funnel, pulling it through so that the sales folks can deal with the top of the funnel and drive demand that way. It's actually optimizing around a number of different ways that we get the communication and the message out there.

Dennis Ding, Biotech Research Analyst, Jefferies: Yeah. Okay. Moving on to XPHOZAH, maybe just talk about what has happened over the last 12 months and some of the challenges there, I guess, structurally with the industry. When do you expect that dynamic to recover for XPHOZAH?

Mike Raab, CEO, Ardelyx: Yeah, I guess one way we think about it is challenges are things that we expected to occur, right? When we made the decision to do this, it was knowing that we were going to go into a way of looking at this business that no one had done before, right? It is unfamiliar, and it takes an awful lot of time to help people understand why we made the decision, the impact it is having, and why the opportunity is so significant that we believe, even though the Medicare population is no longer part of the market where we sell the drug, we service those patients who qualify in our patient assistance program. It is not that the Medicare patients do not get therapy. They do because this is incredibly important. Where is the evidence of that?

The evidence is there are more patients today that can access XPHOZAH than they ever have been able to. It's just not as visible because you don't see prescriptions for non-revenue product. The confidence that we have in where we're going and the journey that we're on over this next year plus as we enter 2026 and ending there because that's when the TDAPA period that you referenced ends. If you look at what's occurring during that period of time, the binders are an important part of how the base rate that ultimately the dialysis providers are going to get an interest in. That's important to them, right? It's an infrequent time that it occurs where that base rate is increased for the surface of dialysis. It's an incredibly low-margin business for them. We understand where the priorities are.

At the same time, the XPHOZAH team is out there messaging how critical it is to make sure that we get the serum phosphorus at the right level. It's an independent predictor of morbidity and mortality for these patients. It matters. It's working in the way that we're doing it. It's just a confusing environment for everyone. Once we're through this TDAPA period, a lot of that dynamic is going to settle out. We're going to be able to be working with the dialysis providers and saying, "Your path to supporting these patients, where this is not going to be an impact on your cost or anything, is to work directly with us and make sure that we can serve these patients." Yeah. Anything to add?

Eric Foster, Chief Commercial Officer, Ardelyx: Yeah. I mean, I think the key point for me is our commitment to patient access. That was the root of our strategy coming into 2025 to make sure that we preserve that. We were able to do that. The next thing for me is, can we then grow the business? What you have seen is steady and consistent growth quarter over quarter with XPHOZAH. If you're a Medicare patient, we have a patient assistance program. If you're a commercial and Medicaid patient, you can go through your prescription benefit. Physicians can have confidence if they have a patient that needs XPHOZAH, and we know that there, unfortunately, are quite a few out there that they can have access. I think that's really a key piece for people to understand.

Dennis Ding, Biotech Research Analyst, Jefferies: Yeah. Okay. To sort of clarify, because this whole bundled payment TDAPA situation is very complicated and confusing, but essentially what you're saying is that dialysis centers during the TDAPA period, they have an incentive to use these binders as often as they can so that the bundled rate goes up and that they would be able to presumably be reimbursed more for each dialysis center session. That period ends in, I guess, beginning of 2027, where there is an opportunity for XPHOZAH to kind of come back into focus for some of these dialysis centers.

Mike Raab, CEO, Ardelyx: That is certainly the opportunity here, right? We do see that there is a priority across a number of the different dialysis providers that are working, but it is for them, this period is critical for them to get a base rate increase.

Eric Foster, Chief Commercial Officer, Ardelyx: Yeah. I would say, here's what we do know. There is a need for XPHOZAH. The dialysis organizations in 2027, they're going to need to manage their patients' phosphorus. XPHOZAH is a great option to be able to do that. They will continue to have access to XPHOZAH just as they do today. We are very committed to patient access and making sure that those in need can have the product. We expect that to be the case in 2027 as well.

Dennis Ding, Biotech Research Analyst, Jefferies: Okay. So then how should we think about the growth in XPHOZAH in 2026 and 2027 without giving guidance, obviously? Just in terms of the trajectory, I think this year, maybe it's around $110 million, but you've also given long-term guidance of $750 million, right? Just help us bridge the gap between where you guys are now and the $750 million.

Mike Raab, CEO, Ardelyx: Yeah. I mean, it's tempting to try to give a very direct answer in terms of 2026 and where we will end in 2027. Will 2027 look like is premature at this time because it continues to be a confounding and odd environment. It's unlike any other drug that we all think about in our businesses. For us, what we look at and why we've given guidance to peak of $750 million is our TAM went from 550,000 patients to 220,000. Really easy way to think about what's occurred. We continue to service those 330,000 patients through our patient assistance program because they need phosphorus management. We're the option for it. If you look at our guidance as to how we get to that $750 million, looking at the average cost per annum for these patients on XPHOZAH, it's about $12,500 per year.

You divide that $750 million by that, and it's 60,000 patients. You get to 30% of the patients of the TAM where we know the benefit is providing them in lowering serum phosphorus. That's where that $750 million comes from. Plenty of time, certainly well before LOE, that we think that that could occur. That's what we want people to focus on, not the period that we're in right now.

Dennis Ding, Biotech Research Analyst, Jefferies: Okay. Remind us around the appeal situation with the court case against CMS, just where we are there. When do you think we could get an update?

Mike Raab, CEO, Ardelyx: Sure. I mean, I'd love to be able to say that we're going to get it in a certain period of time. I think there is no statutory requirement for the court to read out their opinion. And so for us, we're going to say it's six to nine months. It could be sooner. It could be towards the end of the summer next year.

Dennis Ding, Biotech Research Analyst, Jefferies: Got it. Okay. If we can talk a little bit about the pipeline. You guys made a recent announcement on Q3. Just talk a little bit more about that, why that specific asset you chose to move forward.

Mike Raab, CEO, Ardelyx: Yeah. I mean, when we started looking at NHE3 inhibition with a non-absorbed molecule in 2008, the amount of medicinal chemistry and thought that went into creating these molecules is really significant over about a decade of time. In that process, one of the things that we began moving into after we'd already determined that tenapanor was going to be the molecule we were going to take forward, there were other chemotypes that we were looking at. 531 is what we referred to when we announced at our Q3 earnings. It's a far more potent, far more soluble molecule, which may open up other opportunities for us. If you look at solubility, that may matter. If you look at even our current indications, right? This is a gut-restricted molecule. Everyone here in this room is going to have different intestinal flora.

You're going to have different mucosal layers within your GI tract. Solubility may help that for those patients that don't respond as well to Tanafenor today, right? Within our therapeutic areas, to be able to provide the benefit that we see with NHE3 inhibition is certainly one to consider. Potency, where you begin to look at when we started this, we thought this was simply a constipation drug. Block sodium, waterfall of salt. That should help constipation. We then determined that, wow, we may have a benefit in pain given some preclinical work that we've done. That then proved true within the human studies that we did. The mechanism of that was TRPV1, a long-looked-at way of looking at pain relief. We have that benefit.

We were looking at other biomarkers that we saw in our human studies and learned that we were also blocking the absorption of phosphorus. My experience going back to my days at Genzyme with Renagel, there was always this unknown way that phosphorus is primarily absorbed through the GI tract. We deconvoluted that in determining that it was a pericellular space between the cells and the epithelial of the GI tract. Can we decouple some of those things with a more potent, more soluble molecule? Those are the sorts of things that we can begin to explore, as well as many of the other biological associations of what NHE3 might do. When people are asking specifically what the indication would be, it's premature.

We want to follow the science first and foremost because it has told us so much in this journey in looking at how NHE3 with a non-absorbed drug works that there may be other things that we can deconvolute and uncouple. We are patient. We want the science to lead us there. The clinical medicine will then show us the next phase of where we might deploy and which indication we would pursue.

Dennis Ding, Biotech Research Analyst, Jefferies: When should we get the next update from that program?

Mike Raab, CEO, Ardelyx: I can't give you a specific date. We certainly will be filing an IND at some point next year. I think they're actively receiving some more info.

Dennis Ding, Biotech Research Analyst, Jefferies: Okay. Given the greater potency, why shouldn't people, as a base case, look at that asset and think about lifecycle management for IBSRELA beyond 2020?

Mike Raab, CEO, Ardelyx: Absolutely. That is one that is a natural one to pursue. There is no one saying that that should not be done. I also do not want to limit our thinking and our imaginations as to what might just be that.

Dennis Ding, Biotech Research Analyst, Jefferies: Okay. If I can ask a question just around OpEx and just the overall cost structure of the business, maybe remind us, when do you expect to be profitable? Should we start thinking about 2026, or do you think it's still a little bit early?

Mike Raab, CEO, Ardelyx: No. I mean, I think you should start thinking about 2026. What we said in earnings, and if you just do the math in our release, we were, but for stock-based compensation, we're just under $1 million of positive cash flow. That's a pretty important milestone. Now, as you look at us going forward with stock-based comp and all those sorts of things that hit us in this business, you begin to see that I'm not going to lean into that until I can tell you that consistently we're going to be on a GAAP basis generating free cash flow because that's what we will then invest in the business further. The math is pretty straightforward to see.

The other thing that we said in earnings, if you look at XPHOZAH, which has always been a big question, is as a product P&L, it's contributing modestly, but it's contributing. With stock-based comp, overhead G&A, that's where we have to navigate this next period of time. It is an exciting time for the company as we begin to look at that, which is why we decided to announce 531 because we can now lean into it with the cash that we're generating and build the next generation of NHE3 inhibition. At the same time, with the work that Mike Kelleher and the corporate development team are doing, very judiciously look at things that we might in-license to further build our pipeline and build this enterprise that we've been working so hard to create.

Dennis Ding, Biotech Research Analyst, Jefferies: On that BD point, do you have any initial thinkings in terms of what sort of asset, what stage, therapeutic area?

Mike Raab, CEO, Ardelyx: Yeah. I mean, obviously, the bite that we can take now is limited. I think we're thoughtful looking across all stages because there are opportunities. Me Too and Me Better are really hard to imagine versus ways that if you look at what we've done both with IBS-C and hyperphosphatemia, we're differentiating ourselves within those markets, both in terms of the molecules, the therapeutic area, the therapeutic benefit we provide, and the commercialization approach that we take. I think that's a lens through which we will look at things through all stages of development. Certainly, earlier stage now is more appealing just given the check that we can rank.

Dennis Ding, Biotech Research Analyst, Jefferies: Presumably, there would be synergies with the existing GI/renal call point?

Mike Raab, CEO, Ardelyx: That's a natural one to look at first is our current therapeutic areas. Adjacencies to that also make sense. If you look at our industry and our businesses, we tend to be opportunistic. The way most biotechnology companies grow is there's opportunism that, again, the science and the medicine need to tell you. You look at the team that we've assembled here. This has been an intentional part of my work over the last 18 to 24 months is to build an organization and to build a team of very smart, very capable, diverse thinkers and experiences that can then take advantage of opportunity plus what we currently have in place and build those businesses robustly as we can.

It is by chance that we're in the place that we are right now with the leadership team and the entire organization that we have built over these last years.

Dennis Ding, Biotech Research Analyst, Jefferies: Great. In the last minute, maybe remind us of your balance sheet, cash, runway, etc.

Mike Raab, CEO, Ardelyx: Yeah. We ended Q3 with $242 million. We continue to see that's going to grow over time as we approach cash flow positivity. We will thoughtfully deploy that cap.

Dennis Ding, Biotech Research Analyst, Jefferies: Great. Thank you guys so much for being here. It's great to see you. I'm sort of losing my voice at the end of the day. Look, guys, we're excited to see what you guys have in store for us in 2026.

Mike Raab, CEO, Ardelyx: I think 2026 is going to be a critical pivotal year for the company. As all these things that we've been talking about, how we enter the year, I think, is an incredibly strong position. I think a year from now, we're going to be having fundamentally different discussions about where this company is going. Dennis, thank you, and Jefferies for inviting us.

Dennis Ding, Biotech Research Analyst, Jefferies: Very good. Thank you so much.

Mike Raab, CEO, Ardelyx: Thanks.

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