Ryan Deschner: Hi there. My question is, you know, from our recent discussions with nephrologists over the last few weeks, we’re hearing a heavy interest actually in the perceived compliance benefit associated with XPHOZAH for patient subpopulations, actually both with and without adequately controlled serum phosphorous. So my questions are, how big of a market segment is represented by patients who are failing phosphate binders largely due to poor compliance? And how are you thinking about potentially addressing the market segment represented by patients with controlled serum phosphorous who have strong desire to reduce pill burden, you know, in the future?
Mike Raab: Yeah. I mean, I’ll let, ask Susan to address some of this too, but that second population, you know, that falls potentially within a definition of intolerance, right? If you think about how these patients have had to take these handfuls of pills every day, multiple meals, every meal and snack, that’s a tolerance issue, not necessarily an efficacy issue. So we think that the indication that we were ultimately able to get from the FDA allows a physician to attest to either one of those two. Susan, anything to add?
Susan Rodriguez: Yeah, I would just add that it’s really important to note that consistently we see approximately 70% of patients, despite treatment with binders, are unable to achieve or maintain the, you know, global guideline target levels within a six-month period. So, and what we’re finding now on the market in front of nephrologists is that they believe that the majority of their patients are unable to achieve or maintain target levels with binder therapy. So the population that, you know, aligned with our indication is really quite large. And I think, you know, it’s, and that’s why we’re seeing the enthusiasm on the part of the nephrology community to now finally have another option for those patients. And with the novel mechanism of XPHOZAH as a first-in-class phosphate absorption inhibitor, you know, there’s broad application to be used for those patients that are, you know, inadequately managed despite binder therapy.
On top of that, the intolerance consideration, you know, is another opportunity for use of XPHOZAH. So clearly the compliance benefit is something that people speak to. One small pill twice a day, especially if it’s being added to a therapy regimen, the patients are responding really favorably, like, wow, I could take this. Or if the physician decides to discontinue the binders, now they’re on one pill twice a day. Yeah, that’s really resonating with physicians and with patients. And it’s really part of the momentum driving the use of XPHOZAH. And ultimately, the compliance is so intermingled with why patients have been unable to reach target levels. So we’re quite confident that there’s a really strong opportunity within the labeled claim.
And we’re seeing that in the enthusiasm in the marketplace.
Ryan Deschner: Thanks so much. Appreciate it.
Operator: The next question comes from Joseph Thome from TD Cowen. Please go ahead.
Joseph Thome: Hi there. Good afternoon. Congrats on the progress. And thank you for taking my questions, everyone, on XPHOZAH. And then I’ll have a follow-up on IBSRELA if possible. But maybe first on XPHOZAH, are you able to provide any sort of information on the number of prescribers that have maybe written since launch? Or I guess if you can, going forward, what sort of metrics do you anticipate providing to gauge how the launch is progressing? And then I’ll have a follow-up.
Mike Raab: Hey, Joe. Thanks for the question. Obviously, understandable question given some of the data that you’re accustomed to isn’t available. But we’re not going to be in a position to count physicians and do that. I think as we begin, as we did with IBSRELA, getting the comfort of a number of quarters underneath our belt, ultimately, the revenue guidance that we are going to give is going to be the most important thing for all of you to follow. And presumably, there will be some resolution as to how you can access script data, whether it’s through outlets like you have in the past or acquiring those data as well. And what’s your question on IBSRELA?
Joseph Thome: And then on IBSRELA, I had a question on our ally study, the phase three in pediatric patients with IBS-C. I guess how important are data from this study? How is this progressing? And when you think about that expanded $1 billion market opportunity, does that include patients or a meaningful number of patients at all under age 18? Or would this be an expansion to that number if you’re able to get that on the label? Thanks.
Mike Raab: Yeah, I think very basically, it’d be an expansion. But Laura, if you want to address the question about the trial.
Laura Williams: Yeah, in terms of the pediatric study, I mean, again, we’ve got an ongoing study in patients who are age 12 to 18. And that study is progressing nicely. And we have another study that is planned in pediatric patients’ age 6 to 11. So in terms of those studies, we see them progressing as planned. In terms of, Mike, maybe you want to address the other part of the question in relationship to how that, pertains to additional revenue.
Mike Raab: Yeah, there’s obviously a population there that we would, that would benefit from a product like IBSRELA. I think quantifying that is going to, it’s not something that we’ve done, but it’s potentially something that we would think is an expansion.
Joseph Thome: Great. Thank you very much.
Operator: The next question comes from Ed Arce from H.C. Wainwright. Please go ahead.
Thomas Yip: Hi, good afternoon. This is Thomas Yip asking a couple questions. Thank you for the kind of questions. So first on IBSRELA, can you provide some details on a plan that was previously announced to expand US sales force both in terms of scale and timing of the increase? Should we expect an incremental increase throughout the year or is it contingent on certain criteria for expansion?
Mike Raab: Yeah, I think as you heard in our opening comments, we’re taking the IBSRELA dedicated team from 64 to 124. And as Justin said in his commentary, steady state spend on that we expect would be in evidenced by the third quarter of this year.
Thomas Yip: Got it. Thank you. And then perhaps one more question on exposure. When should we expect the first time to provide revenue guidance? Should we expect something along the line of IBSRELA? In other words, about 12 months of sales before we see a guidance?
Mike Raab: Yeah, I mean, I think that’s prudent. When we see in some of the questions on this call, what the impact is of seasonality, the first quarter, all those things with IBSRELA was four and a half, five quarters underneath our belt before we came out with any guidance.
Thomas Yip: Sounds good. Thank you again for your questions.
Mike Raab: Of course. Thank you.
Operator: The next question comes from Matt Kaplan from Ladenburg Thalmann. Please go ahead.
Matt Kaplan: Hey, guys. Thanks for taking the questions. Just wanted to stick on IBSRELA for a minute. What are you seeing, I guess, for IBSRELA with respect to its use in terms of duration on therapy and are patients using it in a cyclical fashion, kind of come on and come off the drug?
Mike Raab: Yes, Susan, you want to address that?
Susan Rodriguez: Sure. Yes, Matt. So the feedback that we’re getting from the physicians treating patients with IBSRELA is really highly favorable in terms of the patient response to therapy and satisfaction with therapy. Overall, we’re finding that, as you have noted, IBS-C patients overall, when they’re feeling better, tend to want to maybe stop taking the drug, knowing that if the symptoms come back, they would reinitiate therapy. So at this point, we’re finding that that overall behavior is probably consistent regardless of the treatments that are prescribed. But the good news from the marketplace is that physicians are keeping them on the drug and really believe that the drug is working.
Matt Kaplan: Okay, that’s helpful. And then with respect to XPHOZAH, what are you seeing in terms of the current mixture of patients on XPHOZAH in terms of using it in a combo setting versus a monotherapy? And I guess, how do you think that evolves over time?
Mike Raab: I’m not sure we have exact visibility into other prescriptions, right? So this is a, we have a closed system with our ArdelyxAssist program that helps the prior authorization process. Susan, do we have perspective on that?
Susan Rodriguez: Yeah, actually, it’s a great question, Matt. So I think that there isn’t a quantitative answer. But what we could say is based on our experience now in the offices, that we’re seeing physicians adding XPHOZAH to the current regimen and seeing a nice response in phosphorus reduction. We’re seeing patients reducing the binder dose and adding XPHOZAH and also having a favorable experience. And we’re seeing physicians just eliminate the binders and initiate use of XPHOZAH and seeing a response or if they, and then potentially adding back the binder if they need it. So I think early in the launch, what we’re finding is that because of the novel phosphate blocking mechanism and one small pill twice a day, it really gives the physician a lot of flexibility in terms of how to use the product.
And then overall, they’re telling us that the patients are responding favorably and satisfied and they’re seeing reductions in phosphorus levels. So it’s all very encouraging. Over time, we’ll do our own, as we contract this and market research, it would have to be custom work. It’s not really something available through the script data. We’ll have a better understanding on how that cuts. But overall, it really just leads to a broad-based use and seeing XPHOZAH as applicable to a broad range of patients and that they can customize.
Mike Raab: And Matt, I think that’s why we refer, while we’re referring to this as an XPHOZAH-based regimen is it allows the flexibility for clinicians to do exactly what Susan just described.
Matt Kaplan: Great. Well, congrats on the progress and thanks for taking the questions.
Mike Raab: Thanks, Matt.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Ardelyx President and CEO, Mike Raab, for closing remarks.
Mike Raab: Thank you, everyone, for joining us this evening, and especially to those many shareholders who’ve been on this wild ride with us, whether for the past few years, the past few months, or even the past few weeks. I hope that what you’ve seen and heard from us today is that we are thoughtful and measured in how we build our business that we focus on executing on our priorities, and that we have the right team in place. And to that team, Team Ardelyx, I would like to extend a special and heartfelt thanks to all of you for what you do every day to further our efforts to deliver on our mission, and most importantly, to support patients. With that, we can close the call. Thank you, Danielle.
