Ardelyx Inc (ARDX) 2025 Q3 法說會逐字稿

Good day, everyone, and welcome to the Ardelyx third-quarter 2025 earnings conference call. (Operator Instructions) Now I'd like to turn the call over to Caitlin Lowie, Vice President of Corporate Communications and Investor relations. Caitlin, please go ahead

Thank you. Good afternoon and welcome to our third-quarter 2025 financial results call. During this call, we were referred to the press release issued earlier today, which is available on the investors section of the company's website at ardelyx.com.

During this call, we'll 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 will be filed today and can be found on our website at our 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 progress during Q3 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 Q3 ended September 30, 2025, before we open the call to questions.

With that, let me pass the call over to Mike.

Thanks, Caitlin. It’s great to be here with all of you today to share our Q3 2025 results, another standout quarter for both IBSRELA and XPHOZAH. This performance demonstrates the power of our commercial model, the momentum behind our products, the exceptional execution by our team, and the real-world impact that our differentiated therapies are having for both patients with IBS-C and for those with CKD on dialysis.

We generated $105.5 million in product revenue during Q3, representing 15% YoY growth, a signal of strong demand across our portfolio. In January, I outlined four key priorities for Ardelyx this year: one, to accelerate IBSRELA’s momentum; two, to execute on our XPHOZAH strategy; three, to build a pipeline; and four, to continue delivering strong financial performance.

Ten months later, it is clear that the team at Ardelyx is delivering on these key priorities, and as a result, we’re building real, sustainable momentum. I’d like to provide a bit more detail on each of these areas. IBSRELA continues to outperform and is the foundation of our portfolio and the main engine for Ardelyx’s future growth. IBSRELA set yet another record, generating $78.2 million during Q3, a 92% increase over last year.

Demand growth is broad-based and demonstrates how vital this therapy is for patients. The IBSRELA team is doing an exceptional job expanding reach and deepening prescriber engagement and conviction. Every driver that has fueled our success remains strong: a passionate patient community, an engaged prescriber base, and a novel commercial strategy.

We expect this momentum to continue through Q4 and beyond, and as a result, we are raising our guidance, and we expect to generate between $270 million and $275 million in IBSRELA revenue this year. XPHOZAH also had an incredibly strong quarter, generating $27.4 million in revenue, a 9% increase compared to Q2.

The XPHOZAH team is navigating this dynamic market with determination and agility as we execute on our strategy, ensuring patient access, strengthening clinical conviction among nephrologists, and driving prescription pull-through. XPHOZAH is a valuable component of our growth, and we expect its contribution to our business will only grow over time. Today’s announcement of RDX 10531, which we will refer to as 531, is the next-generation NHE3 inhibitor and marks an important milestone for Ardelyx as we reinvigorate our pipeline.

We at Ardelyx pioneered NHE3 inhibition, and with tenapanor, we have the only approved modulator of this pathway on the market. With 531, we may be able to unlock even greater benefit for patients. Early preclinical data demonstrates that 531 is a highly potent, highly soluble molecule that could open development opportunities across a broad range of therapeutic areas. Preclinical and manufacturing activities are underway in advance of a Phase I study.

This investment in 531 reflects thoughtful stewardship of an important internal asset and is our first new development program in more than three years. We are committed to building a broad, sustainable pipeline, capitalizing first on an internal asset while, in parallel, we explore external opportunities. As we build this pipeline, we are taking a disciplined and forward-thinking approach, identifying opportunities where Ardelyx can win.

We are going to leverage our expertise, assets, and scientific, clinical, and commercial leadership to unlock value. 531 is a reflection of that approach, and I look forward to sharing more information on our plans for this molecule as we advance through the development program. Finally, I want to highlight our financial strength.

With the meaningful revenues we expect to generate in 2026 and beyond, we’re extremely well-positioned to thoughtfully invest our capital in current commercial endeavors and to grow our pipeline. We are delivering our four key priorities. We are driving meaningful impact for patients, and we are creating lasting value for shareholders. Before I hand the call over to Eric, I’d like to formally welcome Suhong Leitner to Ardelyx as our Chief Financial Officer.

She’s a remarkable leader who brings deep financial and strategic expertise to Ardelyx, and she’s already making her mark, challenging our thinking, strengthening our plans, and energizing our path forward. She’s joining a highly experienced leadership team with the technical expertise, vision, and enthusiasm to lead and write the next chapter for Ardelyx. With that, I’m pleased to turn the call over to Eric, who will share his perspectives on our commercial performance. Eric.

Thanks, Mike, and it’s great to be with you all once again. The commercial organization continues to operate at an exceptionally high level. Our commercial strategy is strong and continues to be the foundation of our success. We are focused on addressing areas of high unmet need, delivering first-in-class medicines, leveraging a targeted sales and marketing approach to both patients and prescribers, and investing in high-impact patient services programs to improve access. I’m excited to share with you today how this focus drove our performance during Q3. Starting with IBSRELA, the strong demand for IBSRELA continued during Q3, leading to our highest demand quarter since launch. Additionally, we delivered record highs in the following areas. Revenue was $78.2 million, posting 92% growth year-over-year.

We continued to see the strength of our field sales force and the impact of our marketing initiatives, which drove us to new highs in new writers and total writers, reflecting growth in both depth and breadth of writing. This increase in writers also led to growth in new, refill, and total prescriptions. Once again, the increased and focused activity from our field access manager team resulted in improved pull-through rates.

These results clearly indicate that our strategies are working, and our strong momentum continues. We remain focused on the patient, the prescriber, and improving prescription pull-through so more patients can benefit from IBSRELA. First, the patient. IBS-C patients are incredibly engaged and consistently seek information and new options to address their unmet IBS-C symptoms. In fact, more than 75% of surveyed patients report that they continue to experience the symptoms of IBS-C despite treatment on a secretagogue.

In contrast, patients report highly satisfied with IBSRELA. In a poster we presented earlier this week at the American College of Gastroenterology’s annual scientific meeting, 88% of surveyed IBSRELA patients reported treatment satisfaction. Further internal market research also suggests that when patients learn about IBSRELA, they are motivated to ask for the therapy by name; and when they do, physicians are highly likely to prescribe it. Our focus on the patient will continue, and in some areas, we will increase our investment in targeted patient marketing efforts to support our future growth expectations.

Next is the prescribing healthcare provider. The investments we have made in our field-based team and physician marketing efforts continue to demonstrate that HCPs are highly responsive to IBSRELA’s safety, efficacy, and tolerability profile and its differentiated mechanism of action. Once again, we saw increased targeted activity from our sales team, who drove expanded adoption and utilization.

We maintain our focus on driving depth and breadth of prescribing among high-writing HCPs who are frequently seeing patients with IBS-C. Our messages are resonating, and the team will continue to drive clinical conviction and ultimately to identify and prescribe IBSRELA for those in need. Finally, prescription pull-through. The investments we are making in this area are delivering improvements across the patient journey.

Our field access manager team increased their call activity during Q3, translating into increased rates of prior authorization approvals and resubmission approvals. We continue to look for ways to improve the patient experience, lessen the burden on HCPs, and help ensure that every patient who is prescribed IBSRELA gets on treatment. We are focused on addressing critical aspects of the patient and physician journey and maintaining and building momentum as we enter Q4.

As I mentioned earlier, my team and I just attended the ACG annual conference, and we heard directly from many HCPs about the impact of IBS-C and the important role that IBSRELA is playing for their patients. We are committed to the patient community, and we continue to bring important science to HCPs with three posters presented at the conference. I’m incredibly proud of all this team has accomplished, and I look forward to a strong close to 2025 on our path to more than $1 billion peak revenue.

Now turning to XPHOZAH. The team continues to execute and drive demand. In Q3, the team delivered $27.4 million in revenue, a solid 9% revenue growth compared to Q2. This demand-driven growth demonstrates a clear need among patients for XPHOZAH. Our strategy is anchored in access to XPHOZAH for all patients who receive a prescription, regardless of payer.

We are pleased that this strategy is working, and we remain confident in our long-term growth expectations. The team remains focused on driving clinical conviction among nephrologists to prescribe XPHOZAH for appropriate patients, encouraging prescriptions to be sent to Ardelyx Assist to ensure patients get on treatment, and providing important resources to support prescription pull-through. Our steady and consistent progress is evident in the growth we see across a number of key demand indicators.

Total writers grew quarter over quarter. We grew new and refilled prescriptions, which resulted in growth in total dispenses compared to Q2, including increased volume for both paid and patient-assisted prescriptions. In short, more patients have access to XPHOZAH today than ever before. We also saw continued improvement in prescription pull-through following our investment in the field access manager team. Importantly, we saw a second consecutive quarter of growth in the non-Medicare payer segments.

These are all very encouraging indicators, demonstrating that the momentum we experienced in Q2 continues through Q3 as a result of our strong commercial execution. We focused on expanding breadth and depth of XPHOZAH writing among healthcare providers and continue to place the nephrologist at the center of decision-making. We also connect with other stakeholders in the community, including the dialysis providers, renal dieticians, and advocacy organizations that are important to patient care.

We have a broad-based team focused across the patient journey and continue to engage with all stakeholders about the importance of XPHOZAH. I will be joining the team on Tuesday at the American Society of Nephrology’s Kidney Week to engage directly with HCPs and learn from them about the value that XPHOZAH provides.

We also have three posters being presented that will further support our efforts and will highlight the importance of XPHOZAH for patients with elevated phosphorus. Consistent progress will fuel a strong finish to 2025 for XPHOZAH and create a solid foundation for further growth next year and beyond. I am proud of this team and their efforts in this dynamic market. We remain confident in our long-term peak guidance of $750 million.

Looking at Q4 and into next year across our portfolio of products, we will continue to execute our strategies at a high level and create new opportunities for growth. We have the right team and the right focus. We’re making a difference for patients and driving impact across the business, and we remain steadfast in our commitment to bring these important medicines to the many patients in need.

I will now turn it over to Justin. Justin?

Thanks, Eric. Ardelyx delivered an impressive quarter with continued meaningful growth for both products and another record-setting quarter for IBSRELA. We thoughtfully invested to improve our commercial opportunities, restarted our pipeline, and strengthened our balance sheet through significant top-line growth. Starting with revenue.

For the period ended September 30, 2025, we reported total revenue of $110.3 million, an increase of 12% compared to the $98.2 million we reported in Q3 of last year. The growth was primarily driven by an incredibly strong performance by IBSRELA, recording revenue of $78.2 million, an increase of 92% over the same period last year. The team’s focus on driving increased demand for IBSRELA and improving prescription pull-through continues to drive this momentum. The performance was also the result of expected improvement in our gross-to-net deduction, finishing the Q3 at approximately 31%, a slight improvement over Q2.

We expect IBSRELA growth to continue, and as such, we are raising our guidance and currently expect to finish the year between $270 and $275 million in revenue. XPHOZAH delivered another solid quarter of growth, generating $27.4 million in revenue during the Q3 of 2025, an increase of 9% compared to the second quarter of this year. Our gross-to-net deduction of approximately 29% was consistent with the second quarter.

Finally, you will note that we recorded $4.8 million in non-cash royalty and commercial milestone revenue during the quarter, a significant increase compared to previous quarters and last year. We are pleased to share that our partner in Japan, Kyowa Kirin, achieved year-to-date sales levels that triggered a $3.4 million payment, which we passed along to healthcare royalty partners later this quarter. Now turning to expenses.

Q3 expenditures were up compared to the same period of 2024, reflecting our investment in growth, and spending levels were consistent with Q2 of this year. R&D expenses were $18.1 million for the Q3 of 2025 compared to $15.3 million for the same quarter of the prior year. SG&A expenses were in line with our expectation at $83.6 million compared to $65 million we reported in the Q3 of last year and reflects our continued investments in commercial activities to drive growth.

Our net loss was approximately $1 million, or less than a penny per share in the Q3, compared to a net loss of approximately $800,000 in the same period of last year. In addition, our Q3 2025 results included $4.8 million in non-cash revenue, $12.7 million in non-cash stock compensation expense, and $2.2 million in non-cash interest expense.

We are pleased to report positive Q3 cash flow as a result of significant growth on the top line. We finished the quarter with a very strong balance sheet, including $242.7 million of cash, cash equivalents, and short-term investments. As I prepare to step away from the CFO role at Ardelyx, I would like to thank all the investors and analysts who I’ve had the pleasure to interact with over these past five-plus years.

I would also like to thank all of the Ardelyx team members who I’ve had the privilege to work with. I’m delighted to welcome Sue to the team. We’ve had the opportunity to work together in transitioning the various tasks over these past couple of weeks, and you will find her to be a strong and capable financial leader. I look forward to following Ardelyx in the future as I begin my next journey.

With that, I’ll hand it back to Mike.

Thank you, Justin. Not just for the thoughtful commentary that you provided as you finished out your final quarter with us, but for your leadership, your partnership, and support of everyone at Ardelyx. Ardelyx’s Q3 performance was a continuation of consistently delivering on our priorities. IBSRELA’s strength is the foundation of our growth, and the opportunities ahead for this business are significant.

XPHOZAH remains an important contributor to our business. 531 is our re-entry to product development, and our strong cash position demonstrates our focus on being prudent stewards of our resources while investing in growth. I look forward to sharing more updates on our progress in the quarters ahead. Elvis, you can now open the call to questions.

(Operator Instructions) Chris Raymond, Raymond James.

Hey, thanks for taking the question. Best of luck to you, Justin. It was great working with you and hope to in the future. Just some questions. First of all, on IBSRELA. Looking at the, I guess it’s the SpherX data that kind of sticks out to me the most. You guys have now sort of mid-teens share, I think, overall, in the IBS-C market, but first-line share looks like it’s also in the single digits.

Mike, maybe. Obviously, you got a long way to go to compete with LINZESS for front-line share, but maybe just talk about how front-line use is factoring into your long-range sort of plans and what you guys are doing to try to make that more of a lever that you can pull.

And then maybe the next question then on the 10531. I guess you guys didn’t talk about indications for a reason. But just looking at the literature and potential targets for a potent soluble molecule here. There’s some pretty big indications: hypertension, heart failure, maybe some diabetes indications. Are you looking at something as more broad or more of a targeted indication?

I think let me answer the second part first. We’ve got to take some baby steps before we go to the sprint and marathon. I mean, we understand how to develop NHE3 inhibitors exceedingly well. The characteristics of the molecules are extremely unique. And the fact that we’ve got one that’s as soluble and potent as this does open up the opportunity to consider things like what you just described.

It is premature for us to consider what indications until we go through these initial steps. As I said in my comments, the ability that we now have to invest in what we have created in NHE3 inhibition is an incredible strength. I’ll head off questions that I’m sure are going to come that this is well within our ability to spend and get it to the phases of development as we take advantage of the engine that IBSRELA is.

To your questions about IBSRELA, I’ll ask Eric to comment on it as well. I think as we’ve spoken in the past, Chris, the indication in our clinical work was first line. There is nothing in our label, nothing in our clinical work that says it cannot be first line; and the growth that you see in that is completely organic.

When we started this effort to commercialize IBSRELA, we made the intentional decision to position it in a way that is second and third line because no matter what we did with PBMs and formularies, we would never be first-line because we wouldn’t generate the kind of revenue to supplant what they’re getting from current first-line therapies. We are seeing that organic growth because it is a good drug, and experience with physicians who are writing the scripts are being successful in driving those through.

There are millions of patients on GCC agonists right now, 80% or more of which are dissatisfied with their therapy. The market could grow no more, and we would still be able to meet our objectives and the projections that we’ve had. I think it’s a really important way to think about the business. Because the way that we’ve approached this, our target and our commitment to a billion dollars or more is based upon second-line therapy with the established patients that are there and the call points that Eric and the team are pursuing. Anything to add to that, Eric?

Thanks, Chris, for the question. Yeah, the only thing that I would add to that, Mike, is we’re coming off a Q3 where we’ve got all-time highs in new writers and total writers. Clearly, we are doing a great job of expanding breadth and depth and utilization of IBSRELA. With that comes confidence in the product when they see the results and the impact that it can have with patients.

As you mentioned, we know that more than 75% of the physicians or patients that are out there are continuing to experience symptoms, so they need something different. And so we remain committed to our strategy. We’re pleased to see that it does get some utilization first-line, as you noted, that we’re indicated from a first-line basis. But we remain committed and very confident with what we saw in Q3 and the momentum that we’re generating coming into Q4.

Yigal, Citi.

Hi, this is (inaudible) on for Yigal. Congrats on the quarter, and thanks for taking our question. Maybe just two quick ones for us. I know you had commented on solubility and potency, but just wondering if you could provide a little bit more color on what 531 is hoping to solve that was suboptimal versus tenapanor.

So versus tenapanor is one way to look at it. When you have highly soluble, gut-restricted drugs, you may have better penetration into the target of NHE3. Solubility matters to have a molecule do what it needs to do where you’re trying to target it.

Potency will bring you lower doses or better efficacy. And that’s exactly the preclinical work that we’re embarking upon, to understand how best to leverage those qualities of this molecule. As I said in the previous question, it’s premature for us to speak as to whether or not it is to answer questions that tenapanor can’t or if there are other indications that make more sense to pursue.

Got it. And maybe just one more, if I may. It seems like IBSRELA is really continuing to take off due in part to the investment into the Salesforce. I am just wondering, as you’re seeing that there’s still a big opportunity there, is there any consideration for perhaps increasing the Salesforce even further beyond what you had already done to reach that peak 750 as early as possible?

I mean, the one is just a general comment. I’ll ask Eric to comment on the specifics. Every day, we think about where else we can invest in this growth and this opportunity because what we see here in terms of the benefits providing patients, the organic growth that the previous question had in terms of moving into first-line, this is a very good drug that’s helping a lot of people, and there are a lot of people that aren’t being helped by it yet because of the breadth, depth, and reach.

There are many ways to communicate with those HCPs and those patients, and that broad-based approach is what we will always consider. We will always look at new and better ways to penetrate but certainly investing those considerations and investing in whether it’s the fans, the Salesforce is something that Eric always considers.

Yeah, thanks for that question. As Mike said, we’re constantly looking at the data to see where we can continue to drive growth and value. As we’re looking at the Salesforce, just recall we’re now about three to four full quarters in with the expanded Salesforce, and what they’ve done is really raised the bar.

So right now, I’ve got great confidence in this team. We’re well on our path to achieve $1 billion peak year sales. And as we go into Q4, feel really confident about where the team is. We’ll continue to look at the size of the field team, but we remain confident there. I also just want to take the opportunity to remind you, it’s not just the field team.

We’ve got great marketing initiatives out there. We’ve got a wonderful field access manager team that’s focused on pull-through. It’s really a team effort out there that’s driving the growth of IBSRELA.

Fantastic. Congrats on the quarter again, guys. Appreciate it.

Roanna Ruiz, Leerink Partners.

Hey, everyone. Good afternoon. A couple from me. One for thinking about IBSRELA. What pushes and pulls could impact your ability to reach the high versus low end of your new guidance? It did sound like you’re making great strides with new and repeat prescribers as well. Could you give us a little bit more color? What’s resonating there?

Yeah, I mean, I think the guidance reflects our confidence in what we are doing with all the questions you’ve heard previously. I think that increased guidance in the range that we’ve provided is to show you our confidence in what we’re going to deliver this year.

I think Eric can go into some more of the specifics around it, but that should speak for itself. I think, Roanna, you’ve known us over the years that we’ve taken a pretty conservative approach in the way that we provide these numbers, and what we do is give you numbers that we are confident that we’re going to meet. That’s been consistently the way we’ve approached it over the years.

Yeah, like I said earlier, I mean, we’re very confident in the strategy we have. If you think a little bit about what I mentioned earlier, we know that there are millions of patients out there that have been on or are on secretagogues. Again, more than 75% of those patients continue to experience symptoms of IBS-C, and what they need is something different.

We know that this is a multifactorial disease, and they need something that potentially offers a different mechanism with a proven safety and efficacy profile. I mentioned the poster at the American College of Gastroenterology that was just presented showing that more than 85% of the patients out there were satisfied with IBSRELA. We have a great opportunity out there to address a high unmet need in this patient population, and we continue to be confident with the strategy.

Got it. Thanks. One question on 531. It did sound like it’s just the beginning of building the pipeline. I was curious if there are any other targets or molecules that you’re interested in or would consider, and is external BD also an option?

To the second part first, as you know, just under two years ago, we brought in Mike Kelleher to lead our Corporate Development efforts, and he and his team are always looking and speaking to opportunities that are out there. We will pull the trigger on things when the right thing is there for us. As I said in my opening comments, we’re now at a place where we could look at these assets that we had sitting on the shelf because they’re really good. Are there other ones? There may be, but our focus at this point for our internal pipeline, generated pipeline is 531.

Makes sense. Thanks.

Dennis Ding, Jefferies.

Hey, guys. Congrats on the quarter. Two questions for me. One on IBSRELA. You guys are running trials in peds less than 18 years old. Can you help frame the size of that market versus the adults and if that is already accounted for in your $1 billion peak sales guidance? Also, maybe comment on the timing of clinical trials to go into CIC.

Number two, on XPHOZAH. Congrats on the progress there, but there’s still quite a large gap between where XPHOZAH is now and the $750 million you guys are guiding. What are things that are within your control to really accelerate that? Thank you.

Sure. Thanks for the questions, Dennis. If you look at where we are with IBSRELA, the pediatric trials were a commitment that you have to make to the agency. I think if you look at the total prescriptions that are out there for IBS-C, it includes those. The market that we’re all penetrating is relatively small, but any IBS-C drug, those are included in the prescriptions there.

We’ve not specified whether or not we are counting on that to get to the billion because we’re just looking at the total market as the market that we’re penetrating. For CIC, we’ve not spoken of doing anything there. It’s obviously, as I spoke in your last meeting in London, that is obviously one that we would consider. As we have the ability to pay for it, those are the sorts of things we will look at.

As it relates to XPHOZAH, I think as we’ve talked about this, it’s important to note that when we ended last year, we lost 60% of the revenue that was being generated by XPHOZAH in an incredibly tumultuous market for these patients that are depending upon effective phosphorus management to survive in many cases. That turmoil is real. It’s significant.

We just put numbers on the board that are as good, if not better, even having lost that 60% of the revenue for the entire portfolio. The strength of this team and what we’ve done, I think, is what you see in the results that we’re speaking of today. We have great confidence in our ability to get to the $750 million. I will leave it at that because we’ve spoken about the specifics numerous times.

It’s a third of the TAM that we now have of 220,000 patients is what is required to $750 million. If the need is as extensive and significant as we believe it is and demonstrated both by the paying and the patient assistance program patients, the turmoil that’s at that period is turmoil. Once you get past that, likely that’s going to change.

Laura Chica, Wedbush Securities.

Hi, good afternoon. This is Thomas from Laura Chico. Thank you so much for taking our questions today. Just one from us. You discussed gross-to-net for 3Q earlier for XPHOZAH. Any thoughts on gross-to-net dynamics heading into 2026, and how might this compare to 2025 levels?

Thank you, Thomas. Our growth in that was approximately 29% for Q3, and we do think that will be somewhat consistent going to Q4. We’re not in a position yet to discuss specifics around 2026. Look for us to update that in early 2026.

Matthew Caulfield, H.C. Wainwright.

Great. Hi. Thank you, guys. When we think about XPHOZAH and getting those prescriptions filled, should these essentially be primarily filled through Ardelyx Assist and the patient’s pharmacy at this stage, or are there scenarios where the drug could come through the dialysis center experience despite being external to the bundle, for example? Just trying to kind of best understand the patient journey there to access and growth. Thanks.

Yeah, sure. That’s an important question, I think, to really understand how we can make sure that these patients have access. As we said earlier, we remain committed to access for these patients regardless of who the payer is.

On the non-Medicare side, it’s covered through their prescription benefit. Ardelyx Assist can adjudicate it, and they can also work with specialty pharmacies to deliver to the patient. On the Medicare side, Ardelyx Assist can fulfill that through our patient assistance program. Because we did not file for TDAPA, the dialysis organizations are not buying and billing it.

It is important to note, though, what we’ve seen is actually increased access when we think about patients, whether they’re Medicare or non-Medicare. So more patients today have access to XPHOZAH than they ever have before. I think it’s important to note that we’ve got a path to access for these patients, and we’re continuing to be able to address the unmet need for them.

Joseph Thome, TD Cowen

Hi, there. Good evening. Congrats on the progress, and let me add my best of luck to Justin. Thank you for taking our questions.

Maybe the first one on the new program. I guess anything that you can share on the profile of this drug, whether it’s extended release? Or is there a way to, I guess, improve tolerability? Obviously, the NHE3 mechanism does result in some diarrhea. I guess, is that able to be modulated given that it’s kind of (multiple speakers)

Great question. Those are obviously the things that you begin to explore in the preclinical work that you’re doing. We have obviously years and years of experience and knowledge around the translation of what you see in animal models all the way through to human experience. That’s one thing that we would look at. The benefit that we together have learned about what NHE3 inhibition does, right, it’s blocking sodium.

Fundamentally, that’s what it does. It’s tightening the junctions. That’s where it works in phosphorus. That was not predictable. It also has a benefit in pain, which one would never assume that that was the case until you started the IBS-C work.

Those three different things that this molecule, NHE3 inhibition, does open a vista for lots of things to consider, contemplate exactly around the lines of what you’ve questioned. Time will tell. It is early in the process, but we were excited to announce its development.

Yeah, a little bit related to that, I guess maybe can you talk a little bit about why now was the right time? I guess, did you see anything preclinically that you can share that kind of triggered the announcement or anything in the field? I guess, or is it just kind of continued progress and now is the time? I guess, anything around that?

I kind of talked about it in a couple of previous questions. If you look at the balance sheet that we have, we’ve not raised any money for years, and it’s on the basis of what we’re driving with IBSRELA and XPHOZAH that the balance sheet is as strong as it is.

We had a very short dip after the end of or the start of the TDAPA period, and we’re back with a balance that is what was prior to the start of the TDAPA period. That’s an incredible accomplishment. That then said to me and the team, we can begin to afford to explore other things that we might be able to do to build this company. 531 was an obvious choice because it was something we knew pretty well, and we began to pursue that.

I think, as you heard in my comments, I think this demonstrates that we’ve been extremely good and thoughtful stewards of the capital that we have. I think this is an example of how we plan on deploying.

Julian Harrison, BTIG.

Hi. Thank you for taking my questions. It’s great to see another beat and raise for IBSRELA. You’re at more than 70% YoY growth at the lower end of the new range for 2025. Looking to next year and beyond, I’m curious to what extent you think this cadence of growth can persist.

Looking towards the intellectual property state, are you at a point now where you can talk more about how you’re exploring extending exclusivity potentially beyond composition of matter? Are there any pending patent applications that you would highlight as potentially being Orange Book eligible?

Yeah. Great questions. It is exactly what we are doing and should be doing to protect the franchise that we’re building. Yes, of course, those things are all the things that we will contemplate and talk about when we can. I think what’s important about your question is the growth that you see. As you described for IBSRELA, the potential is spectacular, right?

If you look at the number of scripts that we have compared to the market that’s out there and the growth that is being driven by the need that’s out there for the patients by LINZESS and others, that is to our benefit over time. Our belief is that reaching that $1 billion is something that’s well within our control, or we wouldn’t have said that we expect it to be there.

I think as we gain and continue to gain more perspectives and guidance, we can provide more guidance on when and how that is achieved. We’re excited about the future for IBSRELA and what we’re doing now, certainly with IBS-C and hyperphosphatemia with XPHOZAH. This mechanism, these drugs are making a huge difference. It’s the work that Eric and his team are doing to show that conviction in physicians and getting those prescriptions pulled through.

Aydin Huseynov, Ladenburg Thalmann.

Hi, good afternoon. Thanks for taking questions and congrats with a great commercial quarter. Regarding business development activities, just curious on the kind of assets you’re looking for. Is it more like a GI space, or is it more like an early-stage Phase 1 preclinical? Or would you prefer something like phase three, plug and play, or complementary to your commercial portfolio?

The answer is yes to all of that at the right time, right? We’re going to take some baby steps as we can begin to afford to do more. The natural thing is to look at the therapeutic areas and the close adjacencies of the therapeutic areas that we’re currently in.

Like any biotech company, we’re going to be opportunistic as something demonstrates itself. Me too is not very interesting. Even me better, not very interesting. I think this very special and unique way that we approach commercialization is a really important driver of the considerations that we have for things to bring in. That’s the lens from which we look at things. I think in the coming year, for sure, you’re going to be hearing much more of that as we get our legs under us and look at opportunities that we are confident that we will bring in.

Thank you, Mike. One more general question for me. You’re making almost $400 million in annual sales. You give about $7.5 billion long-term guidance, and yet you’re traded on a $1.2 billion market cap. What do you think the market is underestimating? The long-term guidance itself or the future after 2033? Just curious on your thoughts on this.

I’ll be completely transparent with you. We’ve talked about this before. I think there’s an over-index on XPHOZAH, not giving this engine that we have at IBSRELA the attention that it’s due. What you see in terms of the growth and the benefit that it provides us in profit and operating cash for us to reinvest in the business, whether it is to expand our capacity and capabilities on the commercial side, we will be thoughtful and measured in that.

Also, as we look at other things to bring in, it is something that we are looking forward to as we are on the cusp of generating that kind of free cash to build this company even further. I think we don’t get that credit I think if you look at many of the buy and the sell side, they are expecting at LOE, we may or may not make a billion. There’s no consistency even in the way that people look at this product or products and whether or not they’re giving them their due in the modeling that they do.

That’s our job, right, to also work with each of you to work on that. I think it’s a bunch of those things. I can tell you the truth that I hope by now we’re beginning to get out of the penalty box of we’re a show-me story. I think we’ve shown everyone again and again and again a meet and beat. And that this is a substantive, big, and important market, certainly for IBSRELA. As I said in my opening remarks, XPHOZAH is a contributor to that portfolio and will only continue to provide better contribution over time.

Pakar Agrawal, Cantor Fitzgerald.

Hi, this (inaudible) on for Pakar. Could you comment on any potential tailwinds or headwinds in 2026 that we should be aware of for IBSRELA and XPHOZAH? Thank you.

I can't think of any. I think we’re looking forward to getting out of the auspices of what the bundle is doing for these patients and being able to help them to the degree that we believe we can and should. The turmoil is significant. I think that’s not a headwind. I think that’s a tailwind that ultimately is going to help us as we emerge from 2026 with this remarkable product. I think there are only tailwinds for both of them, not only because I’m an optimist, but I think everything that we’re sharing with you today says that we’ve got the wind in our sails that are going to help propel us to, at a minimum, the guidance that we’ve given for peak for both.

That concludes our question-and-answer session. With that, I’ll turn the program back over to our host for any closing comments.

Thank you, everyone, for joining the call today. We entered the fourth quarter with confidence in our strategy and enthusiasm for the future. We have the medicines, the focus on execution, and the team in place to deliver on our vision of a healthier tomorrow for patients.

I’d like to recognize our employees, the people behind every number that we shared today. Their hard work, ingenuity, and resilience continue to drive our success. Together, team Ardelyx is determined to make a difference. I’d like to end by thanking our shareholders for your continued trust and support. We remain focused on driving sustainable growth and creating long-term value for you. With that, we can close the call.