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

Yigal Nochomovitz: Okay. And then one quick one for Justin on the tax and the finances. Obviously, you highlighted a very strong cash position as of yesterday. I’m just curious, you also mentioned that you did report positive net income, although I know that these are driven by, perhaps, some onetime items. But nonetheless, I’m just curious, Justin, if you could kind of give us a sense as to the likelihood that you might need to take use the SLR credit line again? Or is that more of a backup plan and it’s not really something where you’re expecting to be done again?

Justin Renz: I’m sorry, I trouble understanding the second part of your question. You asked about our cash runway because there was onetime items?

Mike Raab: And then whether we’d be accessing the credit that we have or financing the company in the future, how’s that?

Justin Renz: Yes. So we’re very pleased with our third quarter. We’re clearly not in a point yet where we can share where breakeven is but we think a very measured approach to our funding, as you’ve seen. I do think with our internal projections, we can be very flexible and patient. We have until March 15 of next year to potentially draw the next tranche of debt. And so that’s something that, as the team, we’ll evaluate as we see how well XPHOZAH launches and the continued growth of IBSRELA. So it’s something that we want to have the flexibility on. We don’t have any intentions to do a significant equity raise this time. We’re always looking at all of our different ways to raise capital when appropriate.

Mike Raab: Yes. And Yigal, what I’d add to that is SLR has been a spectacular and unique partner in this whole process for us, right? I mean, you think about when we first established a relationship with them, the company was in a very different position. And the terms around this loan are really favorable to us and what we’re able to accomplish with it which is why we drew down the 22.5%. The additional 50 at our discretion is nice to have. And we may, at some point in the future, take that down before the time frame that Justin just mentioned. But I think it’s important that we have taken the approach that we have and have strong partners like SLR to grow the company to where we want it to be.

Operator: The next question comes from Ed [ph] with H.C. Wainright.

Unidentified Analyst: Congrats on the approval in the quarter. First, I wanted to ask about IBSRELA, given the guidance, the new guidance range. If you could discuss sort of what you’re continuing to see as drivers of additional uptake, both with new and existing writers. And then, turning to XPHOZAH. I’m wondering if, with initial sales in the fourth quarter, are you expecting to report quarterly metrics, say, fourth quarter or early next year and sort of disclosing those and tracking those beyond scripts? And then finally on pricing, I know this was already brought off but I wanted to ask how you came to that number as you think about balancing the ability to capture the differentiated value proposition with the patient access and affordability that you’ve mentioned is important for your launch?

Mike Raab: Sure. Let me make a couple of comments on all of those, Ed. And then I’ll ask Susan to address all of them as well. So the IBSRELA uptake dynamic, it’s because the drug works, right? It is something that people are getting the samples and then their first prescription and the drug is doing something that they’ve never experienced before with the products that they’ve previously been utilizing. So that’s really what’s driving us, it’s the experience is positive. And ArdelyxAssistT program that facilitates access is extraordinarily important and a hallmark of what we do and the way that we help patients get access to the drugs that we develop. With XPHOZAH metrics, we’d love to provide as much as we can but we’ll provide what we think is appropriate.

Early in the launch, we want to make sure that as we did with IBSRELA, it’s probably 4 to 5 quarters of these questions being asked and that we’ll do the best to answer them before we’re giving more solid metrics as we see as things evolve. And with pricing, pricing is an art as well as a science. I think, what we have done here given the expansiveness of the entirety of what we do for patients, that this is a completely appropriate price for what this drug brings because there are no other drugs to manage phosphorus that our next line opportunities with a novel mechanism that may very well be the way that we can ultimately get a greater percentage of our patients to goal. And that’s what we should all be focused on is that we, with this approval and the field force out there already, next — this week, with ASN is going to be spectacular.

And we’re all going to learn a lot about this together. And we feel very confident that we have prices appropriately and are going to be reflecting that in uptake over the ensuing quarters that we were together talking about this. Susan, would you like to add anything?

Susan Rodriguez: Yes, Mike. I think in terms of — let me take the IBSRELA aspect of your question first and then touch on the XPHOZAH of pricing. I think for IBSRELA, what we’re finding is — I mean, there are many high-writing physicians who are just beginning to prescribe IBSRELA. And as we get in their office, the frequency and the sampling, we continue to bring on more and more new writers. So that’s really — there is a lot of runway there. We continue to bring on new writers for IBSRELA. And then as I mentioned before, on top of that, the existing writers expanding their use across their patient population. And what we’re finding, even at the third dimension, is the growth driver is as they gain the favorable experience with IBSRELA, they’re expanding their view as they see patients daily in their office on patients who could benefit from IBSRELA.

So we have very, very strong growth dimensions there in view for IBSRELA taking us into the future. I think in terms of XPHOZAH pricing, as Mike mentioned, we consider multiple dynamics. Let’s just talk a little bit about — obviously, we talked about the novelty of the drug, the unmet need and our commitment to patient access. If you look at the CKD pricing landscape, there have been a few innovations launched recently which is really encouraging for CKD patients on dialysis in high unmet need areas like nephropathy, IgA nephropathy, lupus nephritis, those products price in the range depending on — which one, depending to $4,000 to $10,000 a month. If you look at specifically hyperphosphatemia, I know Yigal had mentioned the branded pricing of the product.

If you look at the number [indiscernible] which product they’re on, the expense of granted binders is actually distributed across a pretty broad range which ranges from $1,400 a month to, as we estimate around $2,400 a month. So in that context, to consider the overall CKD pricing landscape, the hyperphosphatemia branded binder range of cost per month, the novel innovation that XPHOZAH represents, we believe that it’s an appropriate price point. You had mentioned the commitment to access, Mike has emphasized this, both for IBSRELA and XPHOZAH, we are quite confident with the program we have in place that we’re going to support the nephrology offices with this prior-authorization submissions so patients can gain access to XPHOZAH and that XPHOZAH will be affordable, either because we can offset their co-pay for commercial patients.

And for patients who can’t afford the product, too, who don’t have local pay [ph] program, they would be eligible for our patient assistance program. So access and affordability really is our primary focus and that’s what’s going to be important to bring XPHOZAH to these patients.

Unidentified Analyst: Very helpful. Look forward to seeing the team later this week in Philly.

Mike Raab: We’ll see you then.

Operator: Next question comes from Joseph Thome with TD Cowen.

Joseph Thome: Maybe the 2 on IBSRELA uptake. I guess, are you seeing physicians — obviously, the drug is launching well. Are you seeing physicians want to use the drug earlier in the treatment line of their patients? Or obviously, we talked about the target, post market [ph]. But are you seeing them want to use it earlier? And then second, we did see the Phase III trial in adolescent patients. I guess, what is the current uptake in adolescent patients between 12 and, I guess, 17, 18 years of age? And what’s sort of the eventual goal of this study? Would it be just to remove that line on the label that said safety and efficacy of the drug aren’t available in pediatric patients as of 18? Or is there something else that can be done with out of the study readout?