Ardelyx, Inc. (NASDAQ:ARDX) Q1 2024 Earnings Call Transcript

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Operator: The next question comes from Laura Chico with Wedbush.

Laura Chico: Just 2 for me. First on XPHOZAH, what needs to happen to hit the high end of the guidance range now for 2024. And then I just wanted to follow up on exposed, the conversation around the current Medicare Medicaid mix. Does that — is that where you’re projecting at a steady state level, you remain kind of roughly even split between Medicare and non-Medicare patients. And I’m just kind of thinking ahead in terms of the revenue that might be more exposed to a TDAPA [ph] environment versus not? If you could just share any color in terms of where you see that payer mix split ending up over time? That would be helpful.

Mike Raab: If you want me to just briefly address the IBSRELA question is it’s execution and everything that we have been doing is what we need to continue doing expanded footprint certainly is going to be a benefit as we said, trained in the field by the end of the quarter. So that’s certainly a big part of it, too. But it’s execution. The patients are there, they’re waiting and when you ask the right questions, if physicians identify and then we help them go through the prior authorization process. Susan, do you want to address the first question?

Susan Rodriguez: Yes, sure. So I think just as anything regarding XPHOZAH at this moment, only having one full quarter under our belt. It’s hard to predict, Laura. I don’t want to give you the impression that this is exactly steady-state. However, it is not unexpected when you just understanding the patient mix in the dialysis setting and the mix that we’ve seen even for — in the IQVIA data for the binder therapies, this is not unexpected. But we need a few more quarters before we can tell you for certain. One thing that’s important is just understanding that the coverage policies have been defined across all the payer segments. So — and I think that’s really what driving the ultimate outcome in terms of the profile. So that is established and will be consistent as we move into the — as we proceed through this quarter and going forward since we have nice coverage policies in place across all those segments.

Operator: The next question comes from Joseph Thome with Cowen.

Joseph Thome: Maybe on XPHOZAH, can you give us a little bit of idea of the proportion of patients that are on free drug or using the patient assistance program as they weigh coverage? And maybe how long does it take to navigate that prior authorization process from a physician writing a script to actually getting the drug. And then second, Mike, you mentioned the cash balance, maybe what’s your appetite to invest in R&D, either internally in the pipeline or maybe go externally and bring something in?

Mike Raab: Let me address both, the first and the last question. Is — it’s early days for us to be sharing what’s on the patient assistance program. So we’re going to wait until we’ve got more experience under our belts with that. And as you saw just under 1.5 months ago, we hired Mike Kelleher as our Executive Vice President, Corporate Development and Strategy. That should be the signal to your question, our willingness to invest in pipeline opportunities with its organic development or opportunities we may find outside as I think what we are demonstrating is that the approach that we take to commercialization of drugs is clearly unique. Our ability to attract remarkable performers in the field, I think, is evidence of what you see in both IBSRELA and XPHOZAH performance. So leveraging that and bringing Mike on board, certainly is a big part of us going in that direction.

Operator: The next question comes from Ed Arce with H.C. Wainwright.

Thomas Yip: This is Thomas Yip asking a couple of questions for Ed. Congrats on the strong early traction and great exposure. Perhaps first question, can you discuss how many patients are on the XPHOZAH therapy to date? And among these patients with the split between GI gastro and then PCP subscribers? And then I have a follow-up question as well.

Mike Raab: Yes, it’s a little bit hard to hear the question but I think you’re asking about the split of patients in GIs versus PCP. I think as Susan has spoken about our targets, it’s high writing, GIs and high writing HCPs who act as other GIs and have big practices. I don’t know, Susan, if you want to add anything more to that?

Susan Rodriguez: Yes, exactly. So we identify — our target audience is 9,000 HCPs that account for 50% of the total IBS-C indicated market. So even though so many doctors write ISB-C scripts the opportunity of really targeting this concentrated group that accounts for 50% is really what drives the IBSRELA opportunity for us. And as Mike mentioned, what we find is that there really isn’t a distinction between PCP and a GI. What we have is the high-writing GIs and then we have high writing non-GI that actually behave like GIs and just decide to take an interest in treating IBS-C and using the IBS-C indicated drugs to manage their patients. So it’s really not a distinction that’s relevant in our go-to-market approach.

Thomas Yip: Got it. And also, can you discuss how many patients are on XPHOZAH for [indiscernible]. And also the script data could be a reasonable indicator for underlying demand of growth?

Mike Raab: I think you’re asking how many people are on 60-day versus 30-day scripts. I think, again, it’s early days for us to be sharing that kind of information.

Operator: The next question comes from Matt Kaplan with Ladenburg Thalmann.

Matt Kaplan: Nice out of the gate launch for XPHOZAH. Congrats there. Just wanted to dig in a little bit more to XPHOZAH’s performance during the quarter, I guess, what that could mean for product demand in 2024 and beyond. But I guess, especially given the high levels of interest you’re seeing in the Spherix [ph] survey. Were these initial doctors kind of adopters that really take on new therapies and then — will it be more difficult to get additional adopters down the line because these are the early on new therapy interest there?

Mike Raab: A quick comment and then I’ll let Susan to address in more detail, is, nephrologists have been trying their entire careers with these patients to get their serum phosphorous levels in check. And they have been woefully unable to a single mechanism of action of binders irrespective of the type of binder that it is. Patients don’t want to take that amount of material — low phosphorous [indiscernible] are unpalatable. It’s really a difficult life. And when a new mechanism of action — like comes in and as Susan spoke in her opening statement about how this is being utilized along exactly what the votes were in our AdCom. It’s really heartening. And I think physicians see the opportunity to finally have a tool in their toolkit that may help their patients get into the target range they’ve been trying to do.

And as Susan said also in our opening comments that we are hearing from patients and from physicians that these effects are sustained. That’s heartening and extraordinarily rewarding that we’re going to have that kind of impact on patients. It is early days, you always are going to have early adopters, right? That’s not an uncommon and phenomenon. But the difference here is there’s not one nephrologist out there that has not struggled with nor 1 patient out that is not struggled with how to manage their serum phosphorus. Susan, anything to add?

Susan Rodriguez: Yes. I would just say the Spherix [ph] data did report a 56% user base and that’s data that was generated in April. So — and what we’re seeing in the field is that nephrologists really want to spend time with our sales team. We’re getting in to these offices, they’re learning about it. And they do have patients in mind once they are detailed on XPHOZAH. So I think it’s more around — it’s not around an early adopter profile as much as every doctor, to Mike’s point, has been managing this challenge of getting these phosphorus levels within target ranges with the limited options they have and now are very open to incorporating XPHOZAH into the treatment regimen to try to do better. So I think that’s pretty common across all nephrologists.

Where it’s going to be important to continue to move the uptake is to expand their thinking where it’s not just that patients that they’ve always had in mind has been so challenging. But now that you have a new tool, as you see these phosphorus every month, don’t wait for multiple reads or try to make everything work for them on diet or other things, the things that they’ve struggled with. Now they should treat these patients because of the expanded treatment armamentarium they have with expose. So that’s what’s going to be important is just moving beyond that first cohort of patients that they clearly were waiting for something new and now adapting their practice to having a blocking mechanism drug like XPHOZAH.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to President and CEO, Mike Raab, for any closing remarks.

Mike Raab: Thank you, everyone, for joining us this evening, including our investors who’ve been on this journey with us. The employees who drive our success, our partners who support us and the patients that we serve. With that, we can close the call. Thank you, operator.

Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

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