Ardelyx, Inc. (ARDX) Q2 2026 Earnings Report, Transcript and Summary

Welcome to the Ardelyx's Second Quarter 2026 Earnings Call. [Operator Instructions] I would now like to turn the conference over to Lisa Caperelli, Senior Vice President of Investor Relations and Corporate Communications. Lisa, you may begin.

Thank you, Jen. Good afternoon, everyone, and welcome to our second quarter 2026 financial results and business update call. Earlier today, we issued our earnings release, which can be found on the investor section of our website at ardelyx.com. Slides that accompany today's call will also be found on our website. On today's call, I am joined by Mike Raab, President and CEO of Ardelyx; Eric Foster, Chief Commercial Officer; and Sue Hohenleitner, our Chief Financial Officer. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties that may cause our actual results to differ materially from those expressed or implied, including those described in our annual report on Form 10-K, our quarterly report on Form 10-Q, which was filed today, and from time to time in other documents filed with the SEC. These forward-looking statements speak only as of today's date, and 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. I will now pass the call over to Mike.

Thank you, Lisa. Good afternoon, everyone, and thank you for joining us today. This afternoon, we issued a press release announcing our Q2 financial results and a revision to our guidance. I'd like to share my perspectives on our release, drivers of those results, and how we're positioning the business for future growth before I turn the call over to Eric and Sue to cover the performance in detail. In Q2, IBSRELA and XPHOZAH generated a combined revenue of $118 million, up 31% year-over-year, the largest quarterly revenue in our company's history. This is a meaningful milestone and it is important to acknowledge. Growth in the second quarter was robust and yet performance fell short of our expectations. To be clear, IBSRELA demand is strong, physician confidence remains, and our view of the long-term opportunity has not wavered, including achieving $1 billion in revenue. As we anticipated with the establishment of the IBSRELA Pharmacy Network, our investment in the field reimbursement team, and with IBSRELA's continued success, payers have implemented significant hurdles that impacted new patient starts and access to IBSRELA. Eric will provide further details in his commentary. The fundamentals of the IBSRELA business remain strong, and by staying focused on execution, improving patient access, and partnering closely with providers, we are positioned to drive continued adoption and create meaningful value for both patients and shareholders. The team had an excellent quarter. Growth continues to be driven by patient need, physician adoption, and a differentiated clinical profile. As you know, on June 26, the D.C. Circuit Court of Appeals affirmed the district court's dismissal of our lawsuit against CMS. As a result, oral-only phosphate-lowering drugs remain in the bundle. With this decision, we have determined that we will no longer pursue further litigation on this matter. Now, while our strategy remains, we recognize the market dynamics ahead of us present challenges to navigate. As we have always done, we remain committed to ensuring patients in need have access to XPHOZAH. Now, taking a step back, we operate in a complex business with significant external pressures and with new ones that emerge almost daily. Even so, we are in an enviable position. We have 2 first-in-class commercial products, both differentiated, growing quarter-over-quarter and year-over-year. Our strengthening balance sheet is driven by top-line growth, disciplined expense management, and a thoughtful capital allocation strategy. We have built a solid foundation, are investing in our future by advancing tenapanor, our next-generation NHE3 inhibitor, and we are continuing business development activities to further expand our pipeline. We are building a robust patent estate for tenapanor, anchored by multiple Orange Book-listed patents, including our '299 patent. We are a well-funded, self-sustaining, high-growth company on the path to sustained profitability in 2027 and beyond. Our enthusiasm and belief in our business, our competitive position, our strategy, and the long-term value we are creating has not changed. Now, with that, I'll turn the call over to Eric. Eric.

Thank you, Mike. IBSRELA revenue grew 33% year-over-year, and as Mike noted, we experienced significant payer hurdles that had a direct impact on access to IBSRELA. While new patient starts have been slowed by these hurdles, we continue to see strong growth in refills and total prescriptions, reaching our highest demand quarter to date. We understand the ongoing market dynamics IBSRELA is facing and are confident that the following 4 actions will position IBSRELA for future growth by addressing increasing payer hurdles and accelerating IBSRELA demand. 1, leveraging our dedicated field reimbursement team, which we doubled in size in the first half of this year, and we've all been in the field as of July 1, to help navigate HCPs' cumbersome paperwork and burdensome steps. 2, reinforcing our continued efforts to drive more prescriptions through the IBSRELA Pharmacy Network, or IPN, to increase fulfillment rates and improve adherence. We deployed additional resources along with our FRMs and sales force to provide patient-focused, high-touch support that improves the patient experience. Our data shows that when a prescription goes through the IPN, it results in higher fulfillment rates, faster fills, and in 1 additional refill per patient on an annual basis. 3, increasing the frequency of engagement with our target HCPs is one of the most important drivers of demand. In Q2, we implemented initiatives to expand our sales organization to 144 representatives to increase the frequency of engagement with our targeted high-writing HCPs. With this expanded sales force, along with our FRMs, we expect to see continued direct and measurable impact. And while early, we are encouraged by the results. 4, we are expanding our patient awareness and engagement initiatives. Alongside our partnership with the LPGA and ongoing omnichannel and digital efforts, we are initiating new direct-to-consumer activities during the second half of the year. Our consumer-facing messaging is expected to increase brand awareness among our targeted patient population, leading to important conversations with healthcare providers, which our experience tells us leads to an IBSRELA prescription. The unmet need remains high for IBS-C patients and highlights the important role IBSRELA plays for patients seeking treatment options. Last year, nearly 7 million prescriptions were written for IBS-C-indicated drugs, reflecting both the large number of patients seeking relief despite existing therapies and the significant patient burden that still exists. While multiple treatment options are available, our internal research indicates that as many as 77% of patients on a secretagogue continue to experience persistent symptoms. The patient need is demonstrated by record highs in Q2 demand, total writers, total prescriptions per writer, and market share since launch, and further supports our conviction in IBSRELA reaching $1 billion in revenue. As we continue to work to execute on the 4 initiatives I just outlined, I am confident that these efforts will address the barriers identified, accelerate adoption, and enable more patients to receive the treatment they need. Moving on to XPHOZAH. We are impressed by the resilience of XPHOZAH as we saw strong momentum in Q2. With more than 550,000 adult patients with CKD on dialysis in the U.S., approximately 80% are treated with phosphate-lowering therapies in an effort to achieve and maintain target phosphorus levels. As the number of patients treated with XPHOZAH grows, our conviction in its value is reinforced. Our priority remains clear, ensuring XPHOZAH is available to patients who need it. In Q2, XPHOZAH generated 27% revenue growth year-over-year. We saw solid growth across key metrics with notable increases in total dispenses of 33% and in paid prescriptions of 25% compared to the same quarter in 2025. In addition, XPHOZAH reached its highest total writers and prescriptions per writer since Q1 2025. While we are encouraged by XPHOZAH performance, we continue to recognize and assess the challenges ahead of us. Our focus remains on enhancing the effectiveness of our commercial approach by refining sales force deployment and strengthening engagement with healthcare providers and dialysis organizations. These initiatives are designed to ensure we're reaching the physicians treating the patients most likely to benefit from XPHOZAH while continuing to build awareness across the nephrology community. I'm confident in the team's ability to drive demand for both medicines by overcoming the access challenges for IBSRELA and maintaining disciplined execution with XPHOZAH in the second half of this year. Patients need our differentiated products as indicated by the growing demand for both IBSRELA and XPHOZAH, and helping more patients with our medicine is our top priority. I will now turn it over to Sue. Sue.

Thank you, Eric. Our second quarter 2026 financial results reflect the ongoing transformation of Ardelyx into a financially strong organization that allows us to leverage our revenue base to fund both our current commercial operations and our advancing pipeline. This quarter, we maintained our focus of turning disciplined capital allocation into a clear strategic advantage. In the second quarter, our total product revenue was $118 million compared to $90 million in the same period last year, representing 31% growth and demonstrating the need for our differentiated products. IBSRELA is our primary growth engine. Our Q2 2026 revenues of $86.2 million increased 33% compared to Q2 of 2025. We are expecting sequential revenue growth in the second half of 2026, with the fourth quarter delivering the highest revenue of the year. XPHOZAH continues to demonstrate resilience. Revenues for XPHOZAH during the quarter was $31.9 million, an increase of 27% compared to the second quarter of 2025, driven by strong demand. Our financial strategy remains focused on driving towards sustainable profitability, which we are now projecting in 2027. We are a well-funded company investing in our growth accelerators, our commercial operations, and our pipeline, all of which require high-impact investments in R&D and SG&A. R&D expenses for the quarter were $26.1 million compared to $15.7 million for the same period in 2025. This increase primarily reflects development activities and patient enrollment costs for the ongoing ACCEL Phase III clinical trial in CIC. SG&A expenses were $101.4 million for the quarter compared to $84 million for the same period in 2025. This increase reflects deliberate investments to address the access barriers and drive future adoption of IBSRELA. Net loss for the quarter was $16.7 million, compared to a net loss of $19.1 million for the same period in 2025. The net loss for Q2 2026 includes $15.3 million for non-cash expenses from share-based compensation compared to $11.7 million for the same period in 2025. We ended the second quarter with $281.8 million in cash, cash equivalents, and short-term investments, and our liquidity remains robust. As previously announced, during the second quarter, we drew down $50 million from our existing arrangement with SLR for general corporate purposes and to enhance flexibility to support our ongoing strategic initiatives, all in line with our capital allocation strategy. Now turning to guidance. We issue guidance based on a high degree of confidence and our ability to deliver. And if things meaningfully change, we are committed to updating those projections. Starting with 2026, for IBSRELA, taking into consideration the current environment and our proactive initiatives to increase access and fulfillment, we have made the prudent decision to lower our full-year 2026 guidance for IBSRELA to a range of $350 million to $370 million. This revised guidance represents annual growth of more than 30% at the midpoint. This would suggest back-half sales would be roughly 60% of the full year, acknowledging increased sequential revenue growth in the upcoming quarters and in line with prior year's growth patterns. Now turning to XPHOZAH. We are reiterating our full-year 2026 revenue guidance to be between $110 million and $120 million. Now moving on to OPEX. With the decision to modify our guidance for IBSRELA revenue, we have proactively taken additional efforts to manage spending and are revising our 2026 OPEX guidance to be below $500 million. We are managing the business with discipline as evidenced by these actions. Moving on to our longer-term guidance. A few things first. Let me be clear. We are still on a path to achieve $1 billion in revenue for IBSRELA. However, with the 2026 revenue revision, we are evaluating the evolving market dynamics and the impact on the timing of this achievement. For XPHOZAH, we have been assessing market dynamics as well as future growth projections in a period of uncertainty. Therefore, it is prudent to revisit our internal assumptions and pull our $750 million revenue guidance. We believe these are the right decisions and at this time are the right actions to take to ensure that any forward view we provide reflects the current reality. As we are on the cusp of profitability and transition into a more steady and measurable cash flow positivity in the near future, our financial strategy is guided by our 3 capital allocation priorities, which remain unchanged. Accelerating IBSRELA growth, actively progressing our pipeline, and maintaining financial strength. In closing, we are funding our own operations and pipeline from our revenue base, and we remain disciplined in our spending, aggressive in our commercial pursuits, and committed to delivering value for both patients and shareholders. With that, I will hand it back to Mike.

Thank you, Sue. The demand for our medicines is evident. We do understand the challenges that we are facing and we've taken decisive action to address them. We remain focused on executing on our 2026 priorities, including growing IBSRELA demand by improving patient access, maintaining XPHOZAH's momentum, building and expanding our pipeline, and delivering strong financial results. I have tremendous confidence in our team, our strategy, and our ability to execute. We are committed to our patients and creating long-term value for our shareholders and thank you for your continued support. With that, we'll open the call for questions. Operator.

[Operator Instructions] And our first question today will come from Roanna Ruiz with Leerink Partners.

Ryan on for Roanna. Maybe can you just talk about the underlying demand metrics that you guys are tracking as you exit Q2 and through July and how that gives you confidence heading into your revised full-year guidance, and then maybe just quickly, can you also just talk about the pushes and pulls that are baked into this new guidance for IBSRELA?

Sure. And so it's all for IBSRELA and not XPHOZAH, correct?

Yes. Correct.

Eric.

Yes. Hey, Ryan. Thanks for those questions. So as we look at performance right now, as we've talked about, you know, we continue to see really strong refills and total prescriptions. So we'll continue to take a look at that. Clearly we're excited about the highest demand quarter that we've had to date. So we're going to continue to make sure that we focus on that as well as prescriptions going into the IBSRELA Pharmacy Network. We know when that happens, we get higher fulfillment rates, faster fills, and on average, 1 more refill on an annual basis per patient. So those are key metrics for us that are giving us confidence as we look into the back half of this year, that we'll continue to be able to have that controlled growth that we expect.

Yes, and the only thing I would add, Ryan, is that, you know, the pushes and pulls that we talked about have all been factored in. So, we've seen the current performance in the first half of the year. We know the friction that we've seen, and we have baked that into the guidance that we have for IBSRELA.

And we'll move next to Dennis Ding with Jefferies.

I had 2 on IBSRELA. So #1, it sounds like demand is fine, but access is getting more difficult. I think that's really the new piece of info for me. Can you give more color on what those hurdles are? Are these scripts still getting filled, but it's taking longer? Are they just getting completely blocked or they're more step edits or what's going on there exactly? And then #2, you guys have called out many times the favorable impact from these specialty pharmacies. It's been around 9 months since that got implemented and you guys have sounded confident the last few months. So is it possible to share a few quantitative metrics on things like how often are scripts being written as a sign of underlying demand but then actually how many of them are actually getting filled over the last few quarters and I'm assuming that portion or that percentage is getting better over time?

Yes, Dennis, thanks for the questions. I'll ask Eric to address most of that. One comment though is, I think what was important as we talked about is starting the IPN back at the end of last year. As Eric has mentioned on every call that we do see better fulfillment rates and on average 1 additional prescription that goes through the IPN and the special network that we've established, and incredibly fortunate that we started it then. I think as I said in my comments and Eric reiterated, it is the extent of the step edits that have been put in place was not something that one would anticipate with this product. We're clearly getting attention given its growth and success, but you hit the nail on the head. The demand is still there. It is just harder for patients to get through, and that's with the work that Eric and the team are doing with the FRMs and IPN.

Yes, Dennis, so to give you a little bit more color on that. So 2 things that we were seeing, so 1, we're seeing more step edits and 2, more stringent prior authorizations. So you're exactly right, what we're seeing is more of a slowing of the new patient starts, so not blocking but a slowing due to those 2 things. So we feel confident around those 4 actions that we've put in place that we'll be able to accelerate demand as well as improve pull-through as we go through the back half of this year. And again, you're right, we were, as I just said, excited about first quarter being the highest, sorry, our second quarter about the highest demand quarter that we've had to date. So we know that those measures can work and are encouraged about some early signs that we're seeing there.

We'll move next to Chris Raymond with Raymond James.

Hey, this is [ Daniel Chon ] for Chris Raymond. You guys have had pretty active business development efforts for a bit of time now. Can you talk about your view on the current environment for finding assets and opportunities in light of all the recent M&A activity going on in the industry? And, you know, as the business has evolved and the markets changed? Has your thoughts or strategy shifted at all over time?

Thank you for the question. We are looking at opportunities every day, and a substantial number of them. It certainly doesn't lack for opportunity. I think we said in previous calls, you kiss a lot of frogs before you find those things that you're going to bring in. So the team is actively looking at a number of things. We prosecuted a number of them and have not gotten over other things that we find as part of the due diligence process, that's what we do. I'm very optimistic that we're going to be able to build this pipeline, certainly as generating the cash that we are. It's an exciting next step for the company. And certainly with what we have with tenapanor, particularly the '299 patent, gives us runway with tenapanor alone that's really quite significant that my guess is not fully appreciated through 2042. And the 531 program as well, if it bears fruit, is yet another leg on the stool that I think is critical for that effort.

Our next question will come from Matthew Caufield with H.C. Wainwright.

Just focusing on the discussed access challenges for IBSRELA, appreciated the color in the comments there so far. But are these factors something that's gotten worse over the past couple quarters? Or in other words, what, if anything, has changed for the access challenges over the past 12 months, for example?

Yes, I'll ask Eric to comment on that. The thing, if you recall, when we talked about how we approach market access is we have taken a position that we wouldn't rebate, negotiate, and discount until there was a need to. And I think what we're seeing here in terms of the step edits and the hurdles that patients are being forced to go through, which is frustrating for everyone, merits the kind of discussions that we're going to begin having and having already with the payer community. This is their business. That's what they do. They put step edits and hurdles in place for patients, and ultimately you look to the manufacturer to offset those things. It's a tough business, but ultimately what we have put in place with the FRMs, IPN, and the team that Eric has built gets us through those hurdles that exist. That's why we structure it and do it the way we do.

Yes, I would just add that when you have the success that we've had really over the past couple of years, one of the things I think that there's a key takeaway here is that payers certainly are paying attention to that. And the speed and the extent to which these more stringent PAs and step edits were put in place and the impact of those, you know, we're not really anticipating that it would be as quickly as it was. But with that, we feel confident about the things that we started to put in motion late last year and early this year, and are pleased right now that we've got the additional field reimbursement managers in the field to be able to work with physicians and patients to navigate those hurdles. And then that's what we are considering as we've looked at the updated guidance that has given us confidence for the back end of this year.

And we'll move next to Laura Chico with Wedbush Securities.

I guess 1, just follow up there, Eric. If I'm doing the math right, I think the new guidance for IBSRELA implies about a 30% increase in the second half over the first half. So, what you're saying is that the deployment of these new people is going to help you facilitate the appeals process and kind of get more of these scripts recovered? Or is it more of a matter, more of a function of getting new starts through the queue or just finding new patients? And then the second question just relates to the comments around IP that you made, Mike. Can you confirm if there've been any ANDA challengers thus far? And I guess, as you're expanding the patent portfolio, I'm just curious if there's other barriers to generic competition entry that we might be, that we should be considering.

Yes, thanks Laura. Just a quick comment on we'll get to the second question first. We won't go into specifics as to whether or not we've gotten challenges at this point, but you can imagine for a product that's growing this aggressively that there's going to be interest. That's something that we certainly anticipate. What's interesting is remember this is a non-absorbed drug, so it is not the PK/PD traditional way that you would use it that you see generic drugs getting approved. And there's product-specific guidance that you can find from the FDA on what it takes ultimately for those approvals. So that is a barrier in and of itself. Our '299 patent, as we talked about, is a critically important patent, albeit a formulation patent. These are complex molecules that we've designed, not as straightforward as simple formulation. The formulation that we use matters. And other IP that we're building around this is exactly to bolster that even further. So we have great confidence in the '299 estate and the others that are coming and that we already have to strengthen that position through 2042 and potentially beyond.

Yes, and Laura, I would add in terms of the focus for the field reimbursement managers, it's really both. It's new patients as well as those patients that were previously identified that are working through the process. So if we think about the field reimbursement managers and they're able to focus on approval rates as well as resubmission rates, it really can address any of those hurdles if it's a new patient or someone previously identified working through the process.

Our next question will come from Yigal with Citi.

I'm just wondering, are you seeing this payer pushback dynamic broadly across the IBS-C categories, so with some of the competitive products as well? And also, is it restricted to just certain plans, you know, like an Aetna or Blue Cross or CVS? Or are you seeing it kind of broadly across all of the payers? And then on XPHOZAH, could you just elaborate a little bit as to why you decided to, just withdraw the $750 million as opposed to revise it down to something that you are more comfortable with?

Sure, let me address that first, Yigal. And we're coming to the end of the TDAPA period at the end of this year. And that is certainly part of it. You look at the PPS that had come out that's currently in comment stage where they're putting in place a quality measure, referred to as a QIP EQIP. And it's the first time certainly that I've seen in my career that there's a phosphorus QIP there. We need to understand the implications of that QIP as well as this post-TDAPA period, how the DOs are reacting to that. There are some binders in development, obviously with some that are currently at the agency. We really want to see how that settles in. And we just thought it was a prudent approach to take a step back from the $750 million. We may come back with that, but I think it's going to be better informed with what we're going to see in the ensuing months with these transitions.

Yes, and the only thing I would add is, again, as I stated in my remarks, when we're looking at this guidance, we need a high degree of confidence in our ability to deliver that. So, I think it was the prudent thing to do while we're looking at this, as Mike discussed.

Yes, and then with regards to are we seeing this across the IBS-C category? So, just remembering that our strategy is a bit different from the others. And so, just focusing on us, you know, what we've seen is just more stringent prior authorization criteria and ensuring that HCPs are adherent to that criteria. We've seen a bit of a shift there, as well as the step edits. And then in terms of how many payers we're seeing this across, it certainly is a meaningful amount to be able to influence the commercial landscape. And so for us, it was really important to dig into that to see what is the real impact to the business, do we understand it, and what are the actions we can put in place to be able to move forward and feel really good about what the team has been able to put together there and certainly leading to the revised guidance and our plan for the back half of this year.

Our next question will come from Julian Harrison with BTIG.

First, with the updated guide, I'm wondering if you have any updated thoughts on the timeline to profitability. How should we be thinking about that? And then second, on CIC, I know we're around a year from top-line Phase 3 data, but would appreciate if you could help us start framing expectations for that data then? What would maybe be a win in your mind? And does CIC addressable with your current sales force? Or are you maybe expanding into a broader call point there if the data are supportive?

Yes, I think just a little bit on the second part of the question, and I'll ask Sue to address the '27 guide that we've just given. Certainly, there is great synergy with the sales force that we currently have, right? Those physicians see both IBS-C and CIC patients. So that makes good sense. If there's a need to optimize the sales force as Eric has done historically, that's certainly something that we will consider. As we've talked about, all sites are up and running, enrollment's going great, and we're on track to deliver data and read that out in the timeframe that you just articulated.

And in terms of the profitability guide, as I have been continuing to say throughout the year, profitability is right around the corner. And when I think about the revenue growth expected, not only through the rest of this year, but as we continue into '27, we know that our cost structure will level out or begin to level out. So our top line will continue to grow faster than OPEX, and that's why I'm very confident in saying that we will be income positive next year. The other thing I would note is even through this year, as sales continue to grow, we are narrowing our losses in the path towards this profitability. Our Q1 loss, if you recall, was about $38 million. This quarter it's $16 million. It's less than it was this time last year. So we're really continuing to narrow that, you can really see that path to profitability.

And our next question will come from Caroline Palomeque with Ladenburg.

So when thinking about coupons or discounting for product, if you implement that, what kind of impact do you anticipate it will have on GTN, or does the current guidance on GTN still stand?

Yes, so our guidance on GTN, you know, we did take that into account in our total year guide. What I've been saying throughout the year is, you know, low to mid-30s, and that still continues to be the case. So we've taken, you know, all of the impacts into account. And, you know, when you really think about our GTN, it's impacted by mix certainly between government and commercial as well as the IRA inflation rebates and then our co-pay and our distribution discounts and things like that. All taken into account, Caroline.

This does conclude today's conference call. Thank you for joining. You may now disconnect.