Ardelyx at H.C. Wainwright Conference: Strategic Growth and Challenges

On Tuesday, 09 September 2025, Ardelyx Inc. (NASDAQ:ARDX) presented at the H.C. Wainwright 27th Annual Global Investment Conference. The company shared its strategic progress with an optimistic outlook on its two drugs, IBSRELA and XPHOZAH, while also discussing challenges such as changes in Medicare coverage affecting patient access.

Key Takeaways

• Ardelyx reported strong growth for IBSRELA, with an 84% year-over-year increase in Q2 sales.
• XPHOZAH achieved over $160 million in its first year, despite Medicare Part D challenges.
• The company is awaiting a legal ruling from CMS that could impact future coverage.
• Ardelyx aims for a $1 billion peak sales target for IBSRELA and $750 million for XPHOZAH.
• Expansion of sales force and patient access programs are key strategies for growth.

Financial Results

• IBSRELA:

- Q2 year-over-year growth in U.S. net sales: 84%

- 2024 revenue guidance: $250 million to $260 million

- 2023 revenue: $158 million

- 2022 revenue: $16 million in the first period, $80 million for the entire year

- Peak sales guidance: Greater than $1 billion

• XPHOZAH:

- First year net product sales revenue: Over $160 million

- Peak sales guidance: $750 million (excluding Medicare coverage)

Operational Updates

• IBSRELA:

- Launched in Spring 2022 with a 34-person sales force, generating $16 million in sales

- Sales force expanded to 64 reps, with sales growing to $80 million

- Third sales force expansion to 124 reps completed in Q3 of last year, with sales reaching $158 million

- Implemented direct-to-patient marketing to engage patients

• XPHOZAH:

- Launched in October 2023

- Implemented Ardelyx Assist program to aid patient coverage and access

- Q2 2024 sales, including free scripts, surpassed Q4 of last year

Future Outlook

• IBSRELA:

- Continued double-digit market growth expected in IBS-C

- Focus on increasing physician writing frequency and patient engagement

- Steady growth anticipated up to the $1 billion peak sales target

• XPHOZAH:

- Growth expected to return despite Medicare Part D challenges

- Long-term opportunities projected to reach $750 million peak sales target

- Awaiting CMS legal ruling to determine future coverage implications

• Pipeline:

- Possible updates on innovation from internal pipelines later this year

Q&A Highlights

• Impact of Medicare Part D Change on XPHOZAH Uptake:

- Affected the entire dialysis community

- Ardelyx Assist program implemented to help patients access the drug

• ESRD Payment Bundle and CMS Legal Proceedings:

- Ardelyx contends CMS overstepped by including XPHOZAH in the dialysis bundle

- A hearing is scheduled for September 25th, with a ruling expected by year-end

- Outcome could maintain current situation or reinstate pharmaceutical benefit coverage to Medicare Part D

• Metrics for Tracking IBSRELA Progress:

- Monitoring new and refill prescriptions, as well as writer performance

For further details, readers are encouraged to refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: All right, welcome back everyone to HC Wainwright’s Global Investment Conference. My name is Matthew Caulfields. I’m a Senior Biotech Analyst here at HC Wainwright. We’re very excited to be joined by Ardelyx, Inc. as our next guest. Here with us is Justin Renz, Chief Financial Officer and Chief Operations Officer, as well as Caitlin Lowie, Vice President of Investor Relations. Thank you very much to Ardelyx for being with us today.

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: Good morning, Matt. Thank you for having us.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Thank you, guys. Maybe to start things off, could you tell us a bit about the high-level progress the team has made in terms of IBSRELA in irritable bowel syndrome with constipation and also XPHOZAH in chronic kidney disease or CKD with hyperphosphatemia?

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: Sure, absolutely. Good morning, everyone. Thank you. Beautiful day in New York City, as always. Caitlin and I are delighted to be here. Thank you, Matt and the HC Wainwright team for having us. Yes, Ardelyx, publicly traded company, ticker symbol ARDX. We are one of the few companies that has successfully discovered, developed, got approved, and commercialized two medicines so far. Small mid-cap company, that’s quite an accomplishment. It’s a wholly owned asset. We’re very proud of our accomplishments over the years. IBSRELA was approved in 2019 for irritable bowel syndrome with constipation. We launched it in spring of 2022. It’s been commercially successful. We did $16 million in its first period and then $80 million in 2023, $158 million last year. This year we’ve got it that we will do between $250 million and $260 million in net product sales revenue.

XPHOZAH was approved in October of 2023 and we launched and we had a very successful first year last year with over $160 million in net product sales revenue. We’ll talk more about that as we go along. We’re very proud of that and more to follow.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Absolutely, a very exciting level of progress. In considering the market opportunities, what do you view as the greatest unmet needs in the IBSRELA market for IBS-C and additionally addressing CKD hyperphosphatemia for XPHOZAH?

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: Yes, thank you. What’s great about our drug is it’s a novel mechanism, and so it really has given both physicians and caregivers and patients a different option to choose for both indications. It isn’t, we’ll get into the science a little bit on the NHE3 inhibition, but it’s a small molecule, one small pill twice a day. For IBS-C, the primary class of drugs and AbbVie and Ironwood and their predecessor companies did an amazing job in launching the IBS-C marketplace when it was prior just over-the-counter medicines. Our drug offers you a different option. If you have IBS-C, you typically have not only constipation but pain primarily in your midsection, and so our drug gives the treating physician as well as the patients a new option. Our drug has been a very strong clinical profile.

When Linzess or Trulance or other GCC agonists or secretagogues don’t work for you, try our drug. For XPHOZAH, again, same general concept. In chronic kidney disease with dialysis, these are adult patients. They’ve been having binders for many years, and so different backbones have been approved and used by these patients for many years. Sevelamer, you know, we have many team members who helped work in the development and approval of Renagel and Renvela back in the Genzyme days. We discovered tenapanor, again, for hyperphosphatemia, NHE3 inhibition. It is a blocker, not a binder, and so our drug is approved in addition to binders or if you can’t tolerate a binder. It gives the treating nephrologists another option to give to their patients to help them get their levels of hyperphosphatemia into the accepted treatment range.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: No, that’s very helpful. This past quarter included 84% year-over-year growth for IBSRELA U.S. net sales for 2Q, increased 2024 IBSRELA revenue guidance, which you mentioned of $250 million to $260 million for the year. What do you view as the most important drivers for new prescriptions and expanded depth of writing?

Casey, Ardelyx, Inc.: Yeah, I think, again, it’s really important to come back to the market, right? There’s an incredible opportunity. There’s a high unmet need among these patients. The data suggests that only about 25% of patients who are currently treated with a prescription therapy are fully satisfied. That leaves a very large 75% of the market of patients who could use, benefit from another mechanism. As Justin said, all of the other approved therapies are in a single class of therapy. IBSRELA is really the only other option if that therapy, that class may not work. The market itself is very large and very open to this. The IBSRELA product profile is very attractive as well. We know from our research that when a physician is delivered with a message about the IBSRELA clinical profile and product messaging, they tend to write.

The more frequently that we can visit them, the more likely they are to write and put additional patients on. From a commercial perspective, we’re looking at the full kind of patient and physician experience. We have a dedicated sales force that we’ve increased recently that allows us to get that additional frequency at our target physicians to drive the top of the funnel. At the same time, we’re looking at how can we pull them through the bottom. We’ve made investments in our market access and field-based market access team in order to pull those prescriptions through. I think when we look at that full patient experience, it allows us to really hit every, every piece of the opportunity.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Great. As we look to the coming quarters and into 2026 and even beyond, how sustainable do you believe this level of double-digit growth could be for IBSRELA in the IBS-C market? What types of trends could you possibly anticipate?

Casey, Ardelyx, Inc.: We believe that the growth is sustainable in terms of the market itself is actually growing. We’ve seen over the last three years double-digit growth, and we expect that market growth to continue. The market dynamics are absolutely there. The product profile is very attractive, and we did raise our guidance this year, demonstrating that we expect growth to continue. We’ve publicly stated we believe this to be a greater than $1 billion drug. The growth is there, and we expect the growth to be very steady and consistent up to that $1 billion.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: So along those lines, you’ve guided to the peak sales of greater than $1 billion for IBSRELA. What are the best ways for investors to think about that trajectory kind of in the coming years even?

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: I was going to say that we are very proud of our launch plans and our execution. When we launched in spring of 2022, we did, as I mentioned, $16 million with a 34-person sales force. We really realized how promotion-sensitive it was and to really get in front of both the treating physician as well as the patient community. We expanded to 64 and our sales grew to $80 million. Last year we completed our third sales force expansion to 124 reps, finished that in Q3 of last year and did $158 million. That team has now been in place for three full quarters. We had our best quarter ever this past Q2 with $65 million net product sales revenue. As we mentioned, we believe we can do at least $250 million in sales. There are a number of patients out there.

The market has grown over the past few years quite a bit. I want to give credit to other companies that have helped build this prescription market for IBSRELA. We’re able to take advantage of that because they’re not, as Casey mentioned, fully satisfied patients. When those products don’t work for you, we give the doctor another treatment option to try on their patients. These patients are very engaged in their care. We have been able to add some promotional materials for direct-to-patient type marketing where they really want to know if there’s another option available to them. Now IBSRELA has given that an option to them in the last few years that didn’t exist before.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Sure. I mean, it seems like a patient population that would be very responsive to DTC marketing to realize that there’s an option out there for them.

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: That’s right. This is a highly engaged community. We’ve done a lot of omnichannel work, taking advantage of social media. It’s a very engaged patient population. We wouldn’t classify ourselves as direct to consumer, but rather more like a direct to patient, really trying to meet the patient where they are in the physician’s office and probably try to give a more targeted approach to our marketing strategy.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Understood. Kind of returning to the mechanism, a key distinction for IBSRELA is its design as a sodium hydrogen exchanger 3 or NHE3 inhibitor. What are the most important attributes of how this mechanism is benefiting IBS-C patients?

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: Sure. Again, it’s a novel mechanism. We talked about how Linzess and Trulance, the name to our GCC agonists, our drug offers a different way of working through this NHE3 inhibition. By blocking at the exchange point, we really allow kind of that the pain is one of the key components that these patients suffer from. In the lumen of the gut, we found that by not being absorbed, we can really help with that pain relief and helping, you know, truly get some, these folks have sometimes as low as one bowel movement a week. It’s a sensitive topic too, right? I mean, back in the day, I know as a younger person, I was always sensitive about this type of area. Now, more and more, we’re getting more comfortable talking about it.

As I mentioned, the engaged patient population wants to ask their doctor, as Caitlin mentioned, not all are well satisfied. We are now offering that new mechanism to give the treating physician another treatment option to offer these patients, which is fantastic.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Excellent. I mean, okay, even thinking kind of more in the near term, commercially, thinking more granularly, what are the most important metrics for tracking IBSRELA’s progress? Do you foresee any headwinds or seasonality impact in the near term, like per second half, 2025 even?

Casey, Ardelyx, Inc.: Yeah, some of the key metrics that we track are looking at the writers, both the addition of new writers as well as how those writers are performing. We want to add new as well as refill prescriptions, and we want new writers to come in and our existing writers to increase the number of patients that they’re putting on therapy. As we look at the second half of the year, the IBS-C market certainly does have some seasonality associated with it. We’ve been fairly pleased with what we’re seeing, so it’s hard to tell how that dynamic might play out specifically for IBSRELA, but we are following it closely. Again, we raised the guidance, so we do anticipate growth for the second half of the year.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Understood.

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: I was just going to say that the first quarter is always a challenge, I think, for most prescription medicines. We were no different than that. There is a little bit of that seasonality, but I say seasonality in the sense of higher gross to net deductions because many plans reset, the prior auth requirements that need to be redone, a little more paperwork. We saw a very strong Q1. It was our second highest demand quarter compared to Q4 and only slightly less. In Q2, again, we saw the growth and return to growth that we had talked about that gave us the confidence to raise our guidance and raise off to a great start.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: That’s been great to see. I mean, thinking more broadly to the platform, there’s also XPHOZAH. It’s important to highlight sort of that commercial progress as well in CKD hyperphosphatemia. With Medicare Part D no longer covering XPHOZAH and oral phosphate binders from January of this year, how has this impacted uptake and kind of key considerations for the team?

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: Yeah, no, it has, right? This was a change to the dialysis community writ large, irrespective of XPHOZAH. We had a very strong launch and a very successful 2024. The dialysis bundle, the DDAPP period, and all of that changed on January 1. Many of the large dialysis organizations were ready for it. Many of the rural, not-for-profit, and other dialysis providers were not necessarily ready for this change. All binder medicines now, besides Ardelyx, the phosphate lowering therapy class, had a change to how they received their medicines. This was a change for everyone in the community. Many patients, unfortunately, still here in September are not getting the medicines that they deserve. It did impact us. We have tried our best to let the nephrologist and the community know that our drug is available through Ardelyx and directly through us, from the manufacturer, through what we call Ardelyx Assist.

We have tried to consistently message the community, please write the script for the patients that need it, either in addition to or when you can’t tolerate the binders, and we will help you get your hyperphosphatemia under control. They reach out to us. We evaluate the coverage. If they’re a paying customer, great. If they are unable to pay or they are on Medicare, that’s also fine. Q1, we did have a little bit of a setback in terms of scripts because of this change. Q2, the quarter that ended in June, counting free scripts as well as paid scripts, was our best quarter ever, even surpassing Q4 of last year. The patients are coming. We’re doing our best to make sure everybody’s aware of this. We have a strong team driving this growth.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: That’s great. For the CKD hyperphosphatemia, how would you characterize the overall market opportunity? I know the team has guided to prospective peak sales of $750 million for XPHOZAH. What are the key considerations and your thoughts on potential market penetration there?

Casey, Ardelyx, Inc.: The hyperphosphatemia market is similar to the IBSRELA market, very large and very established. When we think about the addressable patients, there are about 220,000 CKD patients on dialysis who are within our kind of revenue generation opportunities, so either commercial or Medicaid. When we look at those patients, we know that about 80% of them require some sort of pharmacological intervention to help reduce phosphate in the blood. Of those, about 70% are unable to do it on binders alone. That is the vast majority of CKD patients who would be a potential patient for XPHOZAH. When we’ve done research with our nephrologists, they indicate that about 30% to 35% of patients would be appropriate for the therapy.

We think that if you looked at about 30% of that 220,000 patient market, that really, you know, with our price point and kind of natural growth, can get you to the $750 million. We feel that’s very achievable. XPHOZAH is a really good therapy. It has a great profile, clinically demonstrating to help patients either as a monotherapy or in combination with binders to achieve target phosphorus levels. We think that there’s a great opportunity for the therapy. We saw a very strong launch in the first year, and the growth is returning. I think the main thing we’re trying to say is the long-term opportunities for it will get us up to that number. We just have to work through kind of this new market environment and execute within it.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Right. That’s the, when you mentioned the 30% to 35% of patients being appropriate, that’s out of the 220,000 total.

Casey, Ardelyx, Inc.: Yeah.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Very helpful. Maybe just taking a step back even, you could take a little bit of time to describe sort of the ESRD payment bundle and sort of that impact to people that are newer to the kidney space.

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: Sure. It’s a very long story, and we’ll try to keep it relatively brief. It goes back to the 2000s and the oral-only exclusion for certain medicines for chronic kidney disease patients on dialysis. There were several extensions written by Congress that moved that till December 31, 2024. Unfortunately, Congress did not extend this last year. Effective January 1 of this year, oral-only drugs for hyperphosphatemia were included in the dialysis bundle effective the 1st of this year. Our drug was considered in that class, except that the Centers for Medicare & Medicaid Services has treated us differently. We became aware that we were not going to be included in any base rate adjustment come effective post-DAPA. DAPA stands for traditional drug add-on payment. The dialysis organizations in many cases contracted with binder companies to source the binder. Now the customer, if you will, is the dialysis organization.

They need to buy the binder and then administer it to the patient and then bill the government. That’s their business. We chose not to enter that because we wanted to be independent of that whole process, having the nephrologists be the center of the decision-making. The way the DAPA works, there will be utilization evaluated from two, perhaps three years, depending on how it works out. Right now it’s two years. There will be a change again on January 1, 2027. We have decided not to participate in that because we want to make our drug available to all patients, whether they can pay or not. That decision-making being kept by the nephrologists, as opposed to if it was a protocolized decision by the dialysis organization, would have been a different outcome.

If you are appropriately a patient for XPHOZAH, we want them to write the script, send it to Ardelyx Assist. As I mentioned earlier, we will help adjudicate the coverage and make the drug available to you, whether you can pay for it or not.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Very interesting. How do you see the contribution of Ardelyx Assist kind of evolving over time then as far as contributing to revenue?

Casey, Ardelyx, Inc.: Ardelyx Assist is a really great program and really the investment that we made in helping to ensure that access and affordability are not limiting factors for patients getting on therapy. I think there’s a couple of ways that Ardelyx Assist really helps both products, but has been incredibly important for XPHOZAH specifically. Ardelyx Assist, we have a dedicated pharmacy for our products. When physicians send it to Ardelyx Assist, it’s the best way that we have to ensure that we are, as Justin said, adjudicating the patient appropriately and getting them through all the different patient assistance program offerings and ultimately getting them onto therapy. Within the field, from a commercial perspective, part of our messaging is send all of your patients to Ardelyx Assist and we will then help them do that. It’s a strong field-based message.

Ultimately, within the program, they take all of the patients, look at what the different, if they’re a commercial payment or a commercial patient, what co-pay programs can we offer them? If they are a Medicare patient or otherwise have a financial concern, then we can move them into the other patient assistance program offerings. The strategy for XPHOZAH has always been around ensuring access to patients so that physicians don’t have to think about what a patient’s coverage is. They write only based on need. The only way that works is if we also provide the support to make sure that once that script is written, that we’re pulling them through and the patient’s getting on therapy. Ardelyx Assist is really the crucial point of delivering on that strategy.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Great, which really would drive, you know, further prescriptions because of the willingness of doctors to not have to go through the bureaucracy of, you know, things on their end.

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: We do everything we can to help. It is still sometimes a challenging situation because of the coverages that people have on either commercial front, whether it’s one prior auth, two prior auths, a medical exception, that whole process. We are there to help and we want to do everything we can to make it as seamless to the treating physician as possible.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Oh, that’s great. Kind of changing gears, I know we only have a minute or two left here, but there was also the anticipated September 25th oral arguments for the CMS legal proceedings related to the inclusion in the Medicare end-stage renal disease or ESRD payment bundle. What more can you tell us about the related implications for XPHOZAH of how that could implicate?

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: That’s right. The discussion we just had, we believe that CMS has kind of overstepped in their remit in including XPHOZAH into this dialysis bundle process. We have a hearing on September 25 with the Second Circuit Court in Washington, D.C. Briefs have been submitted by both sides, Ardelyx and CMS. We’ll have about 15 minutes each to present oral arguments. It’s a three-judge panel at the Second Circuit Court. Essentially, the outcomes are relatively straightforward. It could be as is, which is no, the CMS is within their purview to do what they did, and we will carry on as we are now. We want to guide you to that we believe there still is a real market there.

Should they say that CMS has overstepped, they could then either remand it back to the district court to hear this again on the different merits, or they could decide on their own and say, no, CMS overstepped and reinstate pharmaceutical benefit coverage to Medicare Part D, where while it’s currently all part of this dialysis payment under Medicare Part B. If the pharmacy benefit is reinstated, how long that takes to get logistically reimplemented, I don’t know. Also, there’s no statutory timing of how quickly the Second Circuit Court will rule. The briefs have been entered. The facts are relatively straightforward. We expect a decision to come, we hope by the end of this year. There’s no obligation, but that would be great if we were successful to take advantage of that. We don’t want to guide you to that. We’re happy with where we are right now.

It’s such a tremendous drug. We want to make it available to as many patients as possible.

Casey, Ardelyx, Inc.: Right. The $750 million at peak that we’ve guided to does not include Medicare coverage.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Right. Okay. Very helpful. Maybe in our last minute, how do you view the most important near-term catalyst for investors to keep top of mind looking ahead to the coming quarters? Obviously, that outcome will be important, but even into 2026 and beyond.

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: Yes, we have two growing assets. We talked about revenue, again, two commercial products. We are also quietly, and we saw in our 10Q, which we filed in August, that we are doing some earlier stage activities. Be on the lookout for us to talk about additional innovation from our internal pipelines later this year as we grow our two products. We want to do our best to meet and beat guidance and grow the organization.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Great. With that, Justin, Caitlin, Ardelyx, it’s been great to connect again and a very exciting story.

Justin Renz, Chief Financial Officer and Chief Operations Officer, Ardelyx, Inc.: Thank you, Matt.

Casey, Ardelyx, Inc.: Thank you, Caitlin.

Matthew Caulfields, Senior Biotech Analyst, HC Wainwright: Great to see the progress. Thank you, everyone.

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