Ardelyx at Citi’s Biopharma Conference: Strategic Growth Plans

On Wednesday, 03 September 2025, Ardelyx Inc. (NASDAQ:ARDX) participated in Citi’s Biopharma Back to School Conference. The company showcased its strategic growth plans, focusing on its flagship products IBSRELA and Exposa. While highlighting growth potential and strategic market positioning, the company also acknowledged legal challenges and market dynamics impacting its operations.

Key Takeaways

• Ardelyx raised its revenue guidance for IBSRELA, now targeting $250 million to $260 million.
• Exposa’s relaunch strategy aims for a $750 million peak revenue, though no timeline was provided.
• The company is confident in achieving breakeven soon, with ongoing efforts to expand market reach.
• Legal challenges regarding CMS’s definition of dialysis service could impact future operations.
• Ardelyx is exploring international partnerships and portfolio expansion opportunities.

Financial Results

• IBSRELA’s revenue guidance increased from $240 million-$250 million to $250 million-$260 million.
• Exposa is expected to reach $750 million in peak revenue, but no specific timeline was given.
• The Kowa Kirin partnership generates modest but profitable revenue from API supply.
• Management indicated breakeven is not far off, though no specific timeline was provided.

Operational Updates

• IBSRELA’s marketing targets switch patients and some first-line utilization, with a completed salesforce expansion showing results.
• The field access manager team has expanded to improve prescription approvals and resubmissions, with early positive signs in Q2.
• Omnichannel marketing is used to increase awareness of IBSRELA among patients and physicians.
• Exposa’s messaging emphasizes patient access regardless of payer, with an RWE study expected later this year.

Future Outlook

• Ardelyx is evaluating potential out-licensing opportunities outside the US, considering MFN implications.
• The company is exploring portfolio expansion through business development in related therapeutic areas.
• Ongoing studies for pediatric indications and other potential uses for Tenapanor are progressing.
• Management believes the market undervalues IBSRELA’s $1 billion potential.

Q&A Highlights

• Challenges in prescription fulfillment were discussed, with internal market research guiding strategy.
• Ardelyx argues CMS overstepped by including oral-only drugs as a dialysis service, with a hearing scheduled for September 25.
• Ibsrela’s loss of exclusivity is set for August 2033 (composition of matter) and April 2034 (use).

Readers are invited to refer to the full transcript for a detailed understanding of Ardelyx’s strategic plans and insights shared during the conference.

Full transcript - Citi’s Biopharma Back to School Conference:

Yigal Nachimovitz, Biotech Analyst, Citi: We’re gonna start the afternoon session. I’m Yigal Nachimovitz, biotech analyst at Citi. This is our, back to school bio biopharma summit in Boston. If you have questions, if you’re in the audience, just, you know, you can chime in with the microphones. And also the for those listening online, welcome.

So the next session is with Ardellix, and I have with me the senior senior management, Mike Mike Robb, president and CEO Justin Ren, CFO and Eric Foster, CCO. So thank you all very much. Great to see you. Thanks for for coming in. So I guess maybe to start out, Mike, if you want to just kind of summarize where you are with the business to products that are gaining momentum.

Sure.

Mike Robb, President and CEO, Ardellix: Thanks to Gong and to Citi for inviting us. I think we’re at an incredibly exciting time for the evolution of the company where you look at the decision that we made to not participate in TDAPA. First, let’s get that off the table because that’s certainly a question that we get a lot of that strategy is working. We’re seeing since February month over month growth of prescriptions. And you see the total prescriptions whether they are patient assistance and commercial and Medicaid that we’re reading that we’re meeting the place where we had more prescriptions written than previous months.

So the growth is there. Is it growing as fast as we would like? Not yet. But I think the turmoil that the dialysis community is experiencing really speaks to why that is happening. But you do see the conviction of physicians to get their patients on Exposa.

So very excited about that. I think with what you’re seeing with IBSRELA, the growth that we saw in Q2 only continues. And our enthusiasm for having Ibsrela be a billion dollar drug clearly is there if you look at our the growth rate and how that continues. So billion dollars is certainly on the horizon for us and with Ibsrela and excited about the 750,000,000 that we’re confident we will meet, with Exposa.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. Well, maybe we can start with Ibsrela. You know, what are some of the the forces in the market that are contributing to the to the strength and and, you know, how are you messaging in terms of the value proposition relative to, you know, other others that have been, you know, more entrenched in the marketplace longer than you?

Mike Robb, President and CEO, Ardellix: Sure. Eric, why don’t you go ahead?

Eric Foster, CCO, Ardellix: Yeah. Thanks, Yigal. Great to great to be here. You know, the IBS C market is a it’s a large market and a fast growing mark market. It’s, well established.

The past couple of years, it’s grown more than double digits. So we’re very pleased to see that and certainly feel that Ipsrel has had, has contributed to that. In terms of, when you look at the opportunity and really the patient need in the IBS C market, you know, traditionally, patients have really only had one class of of drugs, secretagogues, that they could go to to help with their IBS C. And we know that only about twenty five percent of those patients are satisfied or very satisfied with their treatment. So the opportunity for us is really, a different mechanism of action, one that provides similar efficacy and safety.

So for those patients that are out there that are not satisfied, whether it be through, lack of efficacy of the product or safety or tolerability, we know that Ibsrela really can help those patients out and meet that need for those patients. So we’ve been really pleased with, the growth trajectory trajectory that the brand has been on. Obviously, q two was a great quarter, a lot of momentum as we head into the back half of this year.

Yigal Nachimovitz, Biotech Analyst, Citi: And how do you how do you identify those patients? Because, you know, you can have people that are set up not satisfied with the drug, but then they may not they may not know what what else is out there. Right? So how do how do you get to them?

Eric Foster, CCO, Ardellix: Yeah. Great great question. So, you know, we certainly we have our Salesforce, which, you know, as you know, completed its Salesforce expansion, at the end of q three last year. So we’ve got three, four quarters under our belt and really feel like they’re hitting their stride. We also have great omnichannel marketing that’s out there that’s bringing awareness, greater awareness, of Trella out there, not just to patients, but also to physicians.

And for us, it’s it’s a fairly simple diagnosis, if you will. So does the patient have IBS C? Are they currently on, a treatment for IBS C? And are they continuing to be, or to be experiencing symptoms, or are they not satisfied with that treatment? Maybe IBS C is is getting in the way of their daily activities, and the patient is looking for something else and looking for something new.

And that’s really where we know that Ipsrela can come in and really be a help for those patients that need it.

Mike Robb, President and CEO, Ardellix: I mean, the thing to think about Yuval with that is not until the launch of Ibsrela was there anything really different that a physician could offer a patient. So it got to a place where why would patients keep asking for something when there wasn’t a there there. So I think the work that Eric and the team are doing to educate both the physicians but also the APPs and the staff of gastroenterology practices, finally they now see that there is something different. There’s an option that they can try. And as a physician you can imagine they never would have offered something that wasn’t they didn’t have an option to offer something different.

So I think what we’ve seen in these three years since launch where we’re beginning to gain that foothold that you need and the growth that we’re seeing out of it in terms of seventy five percent of these patients are not satisfied. They’re not getting the relief that they need and it really interrupts their livelihood and the lives that they can lead. So for us, getting that communication out there and the omnichannel work that Eric’s team is doing, very engaged informed patient population to make sure that they ask the physician, is there anything different? I’ve heard about Idrella. Can I try that?

Yigal Nachimovitz, Biotech Analyst, Citi: So that sounds like a lot of the growth is coming from the, essentially, the the switch market, or is there growth from new starts as well? Yeah.

Eric Foster, CCO, Ardellix: Good question. I mean, we certainly do see some first line utilization. You know, I think as physicians have gained confidence and experience with Ibsrela, they’ve gone to it more first line. But due to payer dynamics and and our internal, positioning of the product, we typically, position ourselves after a secretagogue, because we know that there’s a tremendous opportunity out there. Patients need something, something else.

It’s a multifactorial, disease, and so you need, drugs with different mechanisms of action. And there’s a clear, position for Absurlla out there. And, you know, we feel like that’s the right path in terms of focusing after a failure with a secretagog. But, yes, we do see some first line utilization for sure.

Yigal Nachimovitz, Biotech Analyst, Citi: Of course. So there are many dynamics to growing the market, and, you know, we can get get to each of them. But what about just the overall persistence on on therapy? Are you seeing what does the data show you in the market as far as time on therapy versus what the prior options that were not working for people?

Mike Robb, President and CEO, Ardellix: Yeah. What’s interesting is you look at the secretagogues, whether it is a relapsing remitting disease or tachyphylaxis that happens with an agonist from a biological perspective. You do see five or so scripts a year generally. With inhibitor, you don’t get necessarily tachyphylaxis. And our objective and what we see is more refills over time.

That persistence is there. Okay.

Yigal Nachimovitz, Biotech Analyst, Citi: And then to you mentioned the the billion number. You’ve that’s you’ve been saying that for a few It’s launched. A while. Yeah. Yeah.

So that’s coming from what you’ve described, the the the growth in the in the in the switchers. And then, I mean, what about just I mean, price, I guess, has a little bit of an impact, maybe not huge. What what else? Is there just an overall growth of the market period for everyone?

Mike Robb, President and CEO, Ardellix: So honestly, the the market and Eric and I talk about this all the time. The market could stop growing and we get to the billion dollars. Okay. Because if you look at the millions of patients that are being treated today for IBS C, given our price, given our position in the market, you need way fewer than 200,000 patients in order to get to that billion dollars. So if you look at on a patient basis, it is nowhere near the number of patients that are currently on the GCC agonists.

And with seventy five percent of those patients not satisfied with their current therapy, there is ample room to grow within the established market. But as David as Eric pointed out, we’re seeing organic growth through first line therapy. Our clinical trial was a first line indication. We made the decision knowing the dynamics of the market that we would play in the second line space.

Yigal Nachimovitz, Biotech Analyst, Citi: So you’re at the moment, are you doing any sort of post post marketing studies, or you don’t need that at this point?

Mike Robb, President and CEO, Ardellix: So we do have the pediatric indication to commitment to that you make to the FDA, and we’ll always explore other things if it makes sense. But at this point, we’re not besides the pediatric studies.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. Okay. And so so you but you still have presence at conferences and so Absolutely. In regard to, you know, keeping up the marketing.

Mike Robb, President and CEO, Ardellix: We’ll get ACG later this year, and absolutely go to both local and and international conferences.

Yigal Nachimovitz, Biotech Analyst, Citi: So so towards the goal of a billion, you have you haven’t said sort of, like, when. Right? Or have you given any range as far as, like, is this by the end of the decade, or is this by a certain time? Or

Mike Robb, President and CEO, Ardellix: No. I mean, I and I I think that’s that’s certainly the next phase for us to lean into that and give you some more perspectives on it. But at our growth rate with the guidance that we’ve given just for this year, either we need to slow way down after this year to wait to get to a billion or if we keep at the rate of our growth, we’ll get there before LOE for sure. So that’s where I think is we’re trying to get people to understand in terms of the opportunity that ObsElla presents that some of the conservative views, of how this business grows, that’s our job to change those minds.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. And remind us what the guidance what the guidance you just you you raised it a little bit. Right?

Mike Robb, President and CEO, Ardellix: Yeah. Can

Yigal Nachimovitz, Biotech Analyst, Citi: just remind everyone what what it what it was and what it is now? And did you give it for each product

Mike Robb, President and CEO, Ardellix: or total? So no. We gave guidance for Ibsrela from February to February to ’2 February to February to February to February. Exposure, we’re not yet giving guidance. Just given the turmoil that the market has, what we have done is our confident spoken about our confidence that Exposure will be 3 quarters of a billion dollars.

We’ve not given the time frame for either one of the two per peak.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. What what as you grow the product, what else are you learning about, you know, as you scale? Like, what are there new challenges as you scale, or is it is it more of the same blocking and tackling just to finding, you know, finding more people, getting more people on therapy?

Eric Foster, CCO, Ardellix: Yeah. I mean, that’s a good question. I mean, we think the opportunity is there. We know the patients are there. So, you know, if you think about our path to a billion, you have a sizable market that continues to grow.

As Mike said, we don’t need it to grow necessarily to hit the billion, but it it is continuing to grow. We’ve expanded our Salesforce to really drive to the top of the funnel. So now we’re calling on more high writing GIs, more high writing non GIs, and more APPs, so nurse practitioners and and physician assistants. So feel really good about that Salesforce expansion. But it’s equally important to make sure that you’re focused on pulling those patients through.

So when the physician identifies a patient, they’re able to get access. And so as we’ve said earlier, we expanded our field access manager team. We saw early signs of success of that in in q two around resubmissions and approval rates. That’s still very early, in its expansion. That just started April.

So this is we’re moving now into our second quarter of, of that expansion. And then I think as Mike mentioned, we know that we have a very active and engaged patient. So we need to find out ways to better engage them so that when they raise their hand and they ask for Ipsrela, that the physician is aware of it, and they’re able to grant that. So, you know, for us, I I would I wouldn’t say it’s it’s, new learnings, but I think it’s just getting more efficient and tighter around those key components around driving to the top of the funnel, pulling those patients through, driving greater awareness with patients so that they can go in, they can talk to their physician about that that new option that they need with ObsElla. And in fact, they can get the medicine that they need, that the physician feels that they need.

So we feel really confident about those elements of the business.

Mike Robb, President and CEO, Ardellix: And we all hear about it all the time and have our own experiences of how difficult it is to get prescriptions filled. Right? And it’s it is the dynamics around retail pharmacies are it’s a terrible business, very low margin for retail pharmacies. So any distraction getting a prior authorization filled is taking away from what it is that they’re doing day in and day out. So that’s why the fam team that Eric has put in place is so critically important because the Salesforce is driving the input at the top end and pulling those those prescriptions through is critical.

And the system is set up in such a way that it makes it pretty difficult to do that.

Yigal Nachimovitz, Biotech Analyst, Citi: Do you what about going from the patient side? Do you is that something you do much, like, from the social media platforms directly to to consumers? I mean, I see so many so many pharma ads on CNN. It’s unbelievable. Yeah.

Every commercial break. Right? Yeah. But I don’t think I’ve seen Absorrella yet.

Eric Foster, CCO, Ardellix: No. I don’t I don’t think you’re gonna see us on on CNN right now. You know, we’re always looking at different media channels and way way to reach, reach patients. And, certainly, they’re they we need to make sure that we’re driving awareness for these patients. To your point, though, yeah, we absolutely do have a presence on social media.

We see high engagement there. I’m very pleased with the results that we see, we’re and continuing to evaluate those channels to see where we can get the right mix, because driving patient awareness and driving them into the office is definitely a priority of ours and one that we’re gonna be focusing on a bit more in the future.

Mike Robb, President and CEO, Ardellix: And we do know that the rate of if I’m a patient going to see you as my physician, my asking you for Idralla or another therapeutic has a high rate of acceptance. So getting that patient who are already extraordinarily engaged in their disease to be asking for Idralla is is certainly an important part of it that we do.

Yigal Nachimovitz, Biotech Analyst, Citi: Is that trackable data to know that? Because that’s interesting. Right? If you could know, like, whether how that was this therapy was initiated, whether it was came from the patient’s suggestion. I don’t know if that’s information that could be captured.

Eric Foster, CCO, Ardellix: I mean, we do we do kind of your standard, ATU, so, so, you know, awareness trial usage, internal market research data, where we, you know, we look to understand, you know, how many patients are aware. You know, when a physician comes in or when a patient comes in and they ask, you know, for the brand, how what percentage of those patients are granted. But those are internal, you know, research numbers that we use to help kind guide our our marketing strategy and our tactics.

Yigal Nachimovitz, Biotech Analyst, Citi: Yeah. Okay. So you kind of gave a little bit of a notch to guidance a little bit, but you’re obviously watching Justin’s probably watching every day. I think I know he is. So, you know, is there a potential to go a little higher with the guidance, or you just you feel good about it for now?

Mike Robb, President and CEO, Ardellix: Feel good about it now, and, certainly, our objective is always to overperform. Right? I mean, it is I I think you’ve known me and known us a time where it’s almost has become a drinking game for the company that I’m not gonna get over my skis. Right? I’m gonna give you numbers that I have great confidence that we’re going to meet.

And our objective is to make sure that we show you that we can do better.

Eric Foster, CCO, Ardellix: And and just you know, we went into the year at two forty to two fifty. And then with a really strong quarter, we really felt like we’ve got good momentum, and we were able to move that to the two fifty to two sixty range. So just to clarify that number that we moved to two fifty to two sixty.

Yigal Nachimovitz, Biotech Analyst, Citi: Right. Okay. Okay. And this was when did this you first introduced the Ibsrela guidance? Just to give us the history.

Mike Robb, President and CEO, Ardellix: Where where So it was a year after launch Uh-huh. When we first gave guidance for Ibsrela. And that is not an unfamiliar path to us. Just we wanna make sure that we’re confident on the trajectory of where we are. And you look at a non Medicare business for Exposa, it’s on the trajectory that we think it needs to be on.

We wanna see a bit more time as the DOs are going through the TDAPA process for binders. It is a distraction for them looking at what we’re offering. Right? Because we need those dietitians. We need the information from the DOs in order to put in front of insurers the justification and rationale for filling a script.

Yigal Nachimovitz, Biotech Analyst, Citi: Yeah. Well, remind everyone what what what the status is outside of The United States with with this product.

Mike Robb, President and CEO, Ardellix: We have a partnership with Koya Kirin in Japan for hyperphosphatemia only. And in China, we have a relationship with Fosun Pharma for both indications and then in Canada for both indications.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. And how are those helping the the P and L right now?

Mike Robb, President and CEO, Ardellix: Canada’s a small market, so, you know, de minimis. But if you look at KKC, and Justin can address on this, that is a supply agreement Right. That we have with them as, you know, we if you recall when we were going through the valley of death after the CRL, we monetized the milestones and royalties. So there’s nothing today but some manufacturing benefit.

Justin Ren, CFO, Ardellix: Correct. We supply them right now the active pharmaceutical ingredient that they tablet on their own and so they’ve had very good success since launch. They got approved actually right before we did the fall of, 2023. They’ve been doing well, and we we provide a product revenue from our sales to them every quarter. And so we supply them on a regular basis.

It has a modest margin, but it’s profitable.

Yigal Nachimovitz, Biotech Analyst, Citi: So they can take that API and they can they can go for I ideas if they wanted to.

Mike Robb, President and CEO, Ardellix: No. So they only have right side

Yigal Nachimovitz, Biotech Analyst, Citi: of They can’t. They can’t. No. Okay. Yeah.

So what that’s open then.

Mike Robb, President and CEO, Ardellix: It is open. It’s actually the second largest market outside of The US for LINZESS. I think one of the dynamics we all need to be aware of as this kind of question is the right one is with MFN, one needs to be very thoughtful or the the chance of MFN occurring, one needs to be very thoughtful whether or if you out license outside The United States.

Yigal Nachimovitz, Biotech Analyst, Citi: Yeah. You don’t wanna, you know, jeopardize market, you know, obviously, despite possible short term Yep. Upside.

Mike Robb, President and CEO, Ardellix: Exactly right.

Yigal Nachimovitz, Biotech Analyst, Citi: What about Europe?

Mike Robb, President and CEO, Ardellix: Same thing. I mean, if you look at

Eric Foster, CCO, Ardellix: Same story. Okay.

Mike Robb, President and CEO, Ardellix: Same story.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. So you’re being very judicious about We are. What to do.

Mike Robb, President and CEO, Ardellix: It’s the unintended consequence, right, of of the discussions that are occurring. It will potentially prevent patients to benefit from the innovations that happen.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. Well, speaking of MFN, obviously, the related related topic is, you know, supply chain and manufacture. Just where where does it all happen with your API and your full and finish?

Mike Robb, President and CEO, Ardellix: So Europe broadly, and then it’s brought to The States where we do tableting and packaging.

Yigal Nachimovitz, Biotech Analyst, Citi: For for for for both indications?

Justin Ren, CFO, Ardellix: Correct.

Yigal Nachimovitz, Biotech Analyst, Citi: Yeah. Okay. Okay. Alright. So let’s talk a bit about Exposa.

So you’ve characterized it as kind of like a relaunch, which essentially is what it is what it is, although it’s going it’s going well. Is it simpler? Is it simpler now with this situation? I mean, is it easier or in some sense, or is it is it That’s why I

Mike Robb, President and CEO, Ardellix: keep trying to convince Eric because this is a cakewalk. No problem.

Eric Foster, CCO, Ardellix: Yeah. I’m not sure that it’s, I’m not sure that it’s easy, but I’m really proud of the team and what they’ve been out there doing. I think just the continuous contact messaging around access. Regardless of who the payer is, patients have access to Exposa. You know, we started that messaging late last year, been very, persistent in q one and and and q two.

Know, You for me, one was really about understanding is the strategy working. And I think we got really good strong signals of that in q one. And in q two, was can we start to grow the market, and can we start to grow segments? And as you heard me say in in our, earnings call, we have seen very positive signs. More new riders, so growth in new riders q two versus q one, new and refill prescriptions growth q two versus q one, And more patients as a percent going on product, whether they’re through our patient assistance program or the non Medicare payer segments, are going on product in q two versus q one.

Yigal Nachimovitz, Biotech Analyst, Citi: And now this, you know, what’s going on behind the scenes with some of the illegal maneuverings, you know, you’ve characterized that as kind of just pure upside. Don’t expect it. But if it happens Yeah.

Mike Robb, President and CEO, Ardellix: I mean, if if you look at our TAM, which before the TDAPA period was five hundred and fifty thousand patients, get rid of three hundred and thirty thousand or sixty percent of those patients which are Medicare, our new TAM is two hundred and twenty thousand patients. And the vast majority of patients are underserved with binders, but self reported by physicians they think thirty percent of their patients are in need of an additional product for managing hyperbolic leukemia. So if you look at that TAM, those reports from physicians, you need 60,000 patients to get to $750,000,000 So we have plenty of room within the 220,000 patients to generate the revenue that we’ve guided to and continue to be able to afford giving patient assistance to those patients that are on Medicare.

Yigal Nachimovitz, Biotech Analyst, Citi: And right now, you’re at what you’re at a obviously, what prefer a small percentage of the 60?

Mike Robb, President and CEO, Ardellix: Oh, absolutely. Yeah. Yeah.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. But, I mean, it’s very well understood that I mean, it’s everyone knows it’s it’s not a binder, and that’s not a debate anymore, right, or never was.

Mike Robb, President and CEO, Ardellix: I people get confused still, but Okay. Yes. Yeah.

Yigal Nachimovitz, Biotech Analyst, Citi: What about some of the competitors? I mean, now I’m trying to remember. I mean, Auryxia is old now. That’s been out since, what, 2018 or Yeah.

Mike Robb, President and CEO, Ardellix: And it’s part of the TDAPA period.

Yigal Nachimovitz, Biotech Analyst, Citi: That’s okay. There’s And another one Velforo. Referral. Right. How do those enter are those competitive competing with you, or are they just not really are they just you’re gonna add them in to to the

Mike Robb, President and CEO, Ardellix: Well, so if you look at our label, it’s for add on therapy

Yigal Nachimovitz, Biotech Analyst, Citi: Yeah.

Mike Robb, President and CEO, Ardellix: Or when people can’t tolerate the binder. And, you know, if you look at where we are in study that we ran for optimize we called it optimize where you look at a base therapy of binder, you know, you cut the binder in half, keep it the same, or eliminate it, add exposer, far more patients got to goal. So we can work well in concert with binders, which is the vast majority. Because with binders alone, eighty percent of patients never get to the goal that they need to have. And hyperphosphatemia is an independent predictor morbidity and mortality in these patients.

So if you can get more people to goal, theoretically, you then are going to improve their outcomes. And hyperphosphatemia is something that is poorly treated at this point with just one mechanism, which is the benefit that exposure brings.

Yigal Nachimovitz, Biotech Analyst, Citi: Oh, what other other are you collecting any other RWE, real world evidence?

Mike Robb, President and CEO, Ardellix: Do have an ongoing RWE study. We expect it could read out later this year.

Yigal Nachimovitz, Biotech Analyst, Citi: And what would be in in that? What would be what kind of metrics would be

Mike Robb, President and CEO, Ardellix: I think it’s serum phosphorus first and foremost, and we’re gonna collect all all the outcomes that you can get in that period of time. But it’s you know, since launch and certainly through TDAPA this period, you know, this is not gonna be something you filed with the FDA. This is something that’s just giving a perspective of what the benefits are that that you get with Exposa.

Yigal Nachimovitz, Biotech Analyst, Citi: You know, I remember one of the debates back at the, at the was it the first the the first time that the outcome you know, the whole question of not no outcomes data with with this phosphate biomarker. Is there is there still a push in academics amongst the academics to to ever do that?

Mike Robb, President and CEO, Ardellix: I mean I mean,

Yigal Nachimovitz, Biotech Analyst, Citi: it would be obviously, if you had that, it’d be a big tailwind.

Mike Robb, President and CEO, Ardellix: Sure. And and this is a patient population that dies awfully twenty to twenty five percent a year. Right? So to truly determine a specific cause of death and an intervention, statistically, it’s almost impossible to do and would take forever. Academically, there’s always an interest.

Right? As a physician, they wanna know that the medicine that they are giving their patients is gonna have a benefit. We do know if you look over time and certainly now in the period that they’re in greater utilization of calcium based binders, that’s really bad for patients because then it gets deposited in the soft tissue. And non calcium base binders are important. Clearly, with Savalimar, it’s taken over the vast majority of the market.

And still, you’re not getting patients to goal with Exposa, you can.

Yigal Nachimovitz, Biotech Analyst, Citi: Yeah. Yeah. Well, remind me on the just what is the LOE again for the file?

Mike Robb, President and CEO, Ardellix: So it’s April 2034.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. So you still basically have a little less than a decade.

Mike Robb, President and CEO, Ardellix: So Yeah.

Yigal Nachimovitz, Biotech Analyst, Citi: Good. Plenty of time. For for both. This is would be for

Mike Robb, President and CEO, Ardellix: August ’33 is composition of matter. That’s a Durella, and then use is April ’34.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. And did did you ever explore were there other indications that you could would explore or could explore? Or For Exposa? For Tenpinore, just in general.

Mike Robb, President and CEO, Ardellix: Oh, gosh. Yeah. I mean

Yigal Nachimovitz, Biotech Analyst, Citi: else would I mean, if that’s that’s you know, I know you don’t wanna deploy new capital to new projects right now, but I’m just curious if

Mike Robb, President and CEO, Ardellix: Yeah. I mean, we’re getting to the place where that is within the line of sight given where we think free cash when free cash flow is gonna come. But sure. If you look at diversion of sodium tightening junctions in the GI tract and the other benefits that you see with NHG three inhibition, there’s a 100 or more places that we looked at over time. And, you know, we think that NHG three inhibition, writ large, has a potential benefit for a lot of patients.

Yigal Nachimovitz, Biotech Analyst, Citi: Yeah. Portfolio expansion, business development. I mean, I know you look at a lot of things. I’m sure. Say no to most things, which is

Mike Robb, President and CEO, Ardellix: pretty smart. For business development, you have to kiss a lot of frogs. Right? You you just have to. That’s the name of the game.

Bring on Mike Kelleher about a year ago and the team that he’s built. We’re looking at a lot of things where clearly associated therapeutic areas make sense. Our specific therapeutic areas make sense, and we’ll be opportunistic as well. We also back in ’21 when we got that CRL, we did put on to the side a couple of different programs that we found interesting. Right?

The science that created Tenapanor has created a number of other molecules that that we will hopefully be able to revive.

Yigal Nachimovitz, Biotech Analyst, Citi: You had something in, was it hyperkalemia?

Mike Robb, President and CEO, Ardellix: We had hyperkalemia and metabolic acidosis, both of which we put to the side, just given the challenges of that market. And frankly, some of those are probably would go straight into a bundle, which the lack of alignment in terms of innovation for patients and what CMS is trying to do is exactly what we’re fighting against. Because your incentives are against actually developing the things that might end up being in there.

Yigal Nachimovitz, Biotech Analyst, Citi: I mean, I I know that, you know, no one should expect that this to reverse with the whole proceeding with CMS in the bundle, but but I I’m sure you have very good attorneys. So, like, you know, what what is the what is the case that is being made, and is it is it a case that you think is gonna, you know, resonate with with the the whatever circuit of appeals you’re dealing with right now?

Mike Robb, President and CEO, Ardellix: Yeah. I mean, whether or not it’ll resonate is one question. The the basis of our argument is that CMS overstepped its remit. This goes back to the Chevron case that the Supreme Court decided where the rules that or the laws that were established by congress with MIPA in 2008 did not include oral only drugs as the definition of a dialysis service. And that’s the basis of the argument that per Chevron, they’ve overstepped their remit, and that should be changed as a result.

That’s that’s the argument.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. And this and there’s there is something coming up very soon.

Mike Robb, President and CEO, Ardellix: Yeah. So September 25 is the hearing in front of the district court. And

Yigal Nachimovitz, Biotech Analyst, Citi: What’s the what are the scenarios there? It’s like a the how to just up or down? Up or down.

Mike Robb, President and CEO, Ardellix: It would be our estimation. And then And when that happens, there’s no statutory requirement for them to report in a certain period of time. So it could be quick, but it could take longer time.

Yigal Nachimovitz, Biotech Analyst, Citi: And then would you invest like, if they just turned it down, you would appeal or you would just leave it? Or how does it work? Or I

Mike Robb, President and CEO, Ardellix: mean Yeah. I mean, certainly, you can continue it. That’s the whole beauty, theoretically, of our system is you can continue to appeal, all the way to supreme court. That’s not a decision that we have yet made.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. Alright. What other so, obviously, the quarterly guidance and the and the sales isn’t is critical right now. Any other any other catalysts that we shouldn’t be aware of in terms of just, you know, maybe on the on the OpEx side or just any anything that we should be aware of in terms of

Mike Robb, President and CEO, Ardellix: Well, I’m obviously biased, and I’m sitting in the seat that I sit in that, you know, I I I think a very simple catalyst would be even for Ibsrela to get the proper attention and value that it should. I think we have delivered again and again the numbers that we say we’re going to. And I think the vast majority of the sell side don’t yet see a $1,000,000,000 opportunity with what we’re doing with Ibsrela. So let’s say Exposa is on the side for a billion dollar drug given where we are trading today, I think shareholders would benefit from understanding that there’s a an upside to Ardellix and certainly, Ibsrela at a minimum with what we’ve we’ve been executing. And the same then holds true with Exposa.

When you add that into the portfolio, what it is that we’re doing, revenue that we’re generating, profit on the horizon, and how we would reinvest that free cash flow with the kind of excellence that we’ve demonstrated in commercialization development, that’s something that I think needs to begin to resonate.

Yigal Nachimovitz, Biotech Analyst, Citi: What what have you said about the timelines for the the breakeven and getting have you talked about that?

Mike Robb, President and CEO, Ardellix: We’ve not gotten specifics into it. Certainly, we will. But the math’s pretty straightforward if you look at our performance. And, you know, we tell you our top line, tell you what our expenses are. It’s not that far in the in the distant horizon.

Yigal Nachimovitz, Biotech Analyst, Citi: Yeah. The other thing I’ve seen some companies do is, you know, they’ll give guidance for the gear, but then they’ll sort of give more, you know, a little bit less in focused guidance kind of saying a range that we’re gonna get to the number that

Eric Foster, CCO, Ardellix: you’re

Yigal Nachimovitz, Biotech Analyst, Citi: saying by x to y. Right? Or give a CAGR. Like, that kind of

Mike Robb, President and CEO, Ardellix: No. And I think those are kinda

Yigal Nachimovitz, Biotech Analyst, Citi: the those are interesting things you’re thinking about?

Mike Robb, President and CEO, Ardellix: Oh, absolutely. No. I mean, it’s it’s the beauty of the business that we built, it’s relatively simple at this stage. Right? So that’s why, you know, you just look at the math, you get there pretty quickly.

And then factoring in reinvestment of that capital, how and when we do that, absolutely important.

Yigal Nachimovitz, Biotech Analyst, Citi: Okay. Very good. Do we have questions from anyone in the audience? Alright. Well, thank you all.

Appreciate it.

Mike Robb, President and CEO, Ardellix: Alright. You go. Thank you very much.

Yigal Nachimovitz, Biotech Analyst, Citi: Thank you. Thank you.

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