Ardelyx, Inc. (NASDAQ:ARDX) Q3 2023 Earnings Call Transcript

Mike Raab: Sure. And I’ll ask Susan to speak to the IBSRELA uptake. But first, let me address the pediatric adolescent question. That was an interim look at some of the data that was presented. We are still indicated only for adults with IBS-C. So that hasn’t changed. So any insights that we have, I can’t think of any that say that we’re treating adolescents because that’s not indicated in our label nor is first-line therapy, right? I mean if you look at the way that we position this, it is a drug that’s going to be used for patients that are no longer responding to the GCC agonist. Specific feedback as to whether or not people are using it earlier, Susan, do you want to address that?

Susan Rodriguez: Yes. Actually, it’s interesting for — if you recall, we have a very focused approach calling on the highest writing physicians for IBS-C indicated prescription. For those physicians, the patients they see in their office is daily have all been cycled — have cycled through GCC agonist. So very important to think about the context on where we’re focused with IBSRELA. So for those physicians, [indiscernible] typically have already been treated with these products. So it depends on how you define early. What we’re finding is that, because the patients meet already the prior authorization criteria, it’s really the physician’s eagerness in identifying increasingly patients that they believe can benefit from a novel option.

Remember that the overall label for IBSRELA does support [indiscernible] but in our case, focusing on these high writing physicians, it’s really not an issue for the patients who walk into their office every day meet the prior of criteria.

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

Matt Kaplan: Congrats on the strong quarter. Just focusing on IBSRELA a little bit. Maybe Susan, can you talk about how patients are using IBSRELA in a real-world setting now versus the use in the long-term clinical studies?

Susan Rodriguez: Yes, Matt. Actually, what we’re finding, I mean our clinical data package really shows a rapid response to IBSRELA and a sustained response to IBSRELA which is really a piece of our overall product profile and clinical data profile that physicians respond very favorably to. And what we’re finding in the real world is that that has been their experience that patients have responded to IBSRELA. And when they respond to IBSRELA, they continue to have a sustained effect. I mean obviously, you’re not going — it’s not going to be the best — the right drug for every single patient but where the physician feedback really has been quite favorable on their treatment experience, consistent with their expectations based on the clinical data package. And [indiscernible] tracking the launch over time and persistently they’re reporting either moderate or high satisfaction with treatment with IBSRELA and reporting low discontinuation rate.

Matt Kaplan: All right. And then I guess, given the similarities between the IBS-C market and hyperphosphatemia market, in terms of going into these 2 markets with a novel mechanism of action, combined with the unmet need. Can you talk a little bit about the learnings that you’ve had in the launch of IBSRELA that you’re going to apply to XPHOZAH?

Mike Raab: Sure, Matt. Susan, please.

Susan Rodriguez: Yes. So yes, you’re spot on in terms of the parallels between the 2 markets. And a very important learning is the physician interest, because of the limited options that they have had and the recognized unmet need, their interest in the novel mechanism profile, understanding the way the drug works uniquely and its clinical data package. So we’re very much science-based, clinical-based cells, patient-based cell. And also learn the criticality of emphasizing our commitment to patient access and affordability. So physicians, really, they prescribe based on patients needing a drug and it’s important that we encourage them that they do not have to have a concern around the prior authorization process, that we can support that.

We can remind them that they have familiarity with that administrative process with other drugs they write and this one is no different. And in this case, the patients that they’re identifying, who are in need of our novel drug implicitly meet the prior authorization criteria. So all of that will be very critical in really supporting physician uptake, integrating novel mechanism XPHOZAH into their treatment patterns for these patients who have, for so long, have had no options outside of binders.

Mike Raab: And Matt, what I would add to that is the power of ArdelyxAssistT and the comprehensiveness of that program, when physicians utilize it in a way that it’s been designed, I think they find an extraordinarily seamless program where they get confidence that if they’re going to write a script, that their patient is going to get it, irrespective of whether or not it’s a co-pay paydown, it’s an affordability issue, Medicaid, Medicare, Ardelyx is there to accomplish an awful lot. So it’s really the — that program and how physicians and ultimately the patients who are receiving, whether it’s IBSRELA or XPHOZAH are finding that ArdelyxAssistT is really doing the job that it’s been designed to do.

Matt Kaplan: Okay, great. And then, last question. Can you provide a little bit more detail on the presence that you’re going to have at the upcoming ASN meeting later this week?

Mike Raab: Sure. Susan?

Susan Rodriguez: Yes. So we will have a very strong presence for XPHOZAH at the upcoming ASN meeting, we will have a strong promotional booth presence, reflecting our whole launch campaign for XPHOZAH. As we mentioned earlier in the narrative, we have a sales force out and deployed calling on nephrology health care providers as we speak. So we’ll have a strong promotional presence at ASN. Reminder at banners, I think anywhere you look across the ASN floor, you’re going to see XPHOZAH and its novel blocking mechanism campaign. We also have a clinical scientific presence at ASN, we’ll have a product theater where we have opinion leaders presenting on the novel product profile of XPHOZAH and its clinical data package. So we’re quite encouraged about all of the events at ASN and hopefully, look forward to seeing you there.

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

Unidentified Analyst: This is [indiscernible] on for Laura Chico. How should we be thinking about gross to net dynamics for exposure pricing over time? And what your steady-state rate expectations for gross to net discount? And then just our last question is, could you perhaps review why IBSRELA, as a competitor, makes sense?

Mike Raab: Let me start with the last one first. It’s a great question, is why does IBSRELA as a competitor makes sense? I think Susan is the best one to address that, given what the experiences Ardelyx is that we’re seeing in the field. And then, I’ll ask Justin to address gross net for XPHOZAH and discounts. Susan?

Susan Rodriguez: Yes. So I think IBSRELA as a comparator, let’s just take a step back and I think it’s some of the parallels that Matt alluded to. So as a novel mechanism drug, a specialty drug, the gross to net components, take into account the distribution, the mandated government rebates and other considerations that [indiscernible] can touch on. Overall and the gross and [indiscernible] between the 2 products, we’re going to need to wait and see because the mix of patients, the payer mix of patients also determines the extent to which the government mandated rebates become a part of your gross to net profile. But what is comparable between the two which is an important comparator, is that there will not be incremental rebates that we’re providing payers for access to the drug.