Ardelyx, Inc. (NASDAQ:ARDX) Q2 2023 Earnings Call Transcript

And if you recall in our last go around, we negotiated the majority of the package insert before what occurred to ultimately end up in the CRL. So I don’t know how much re-litigation is going to have to be required for the PI since that’s already been done. But that’s what we would anticipate.

Dennis Ding: Thank you.

Mike Raab: Thanks Dennis.

Operator: Thank you. And the next question comes from Laura Chico with Wedbush.

Laura Chico: Hey, good morning guys thanks for taking the question. I just want to circle back on the guidance real quick here. What I guess maybe if you could explain Mike, what gave this, why was now a good time to start providing guidance? Was there anything that’s changed kind of in the trajectory or anything there? But yes, rationale around why now is a good time for guidance?

Mike Raab: Well, we said that we’re doing about 15 months to 18 months from lunch as we learn more about the data and got more comfortable and I think as Justin said in his opening remarks that we’re gaining confidence in those numbers being representative of where we’re going. So, and actually were generated and it’s 15 months 16 months first launch and it just seems like the right time. Justin, anything to add?

Laura Chico: Okay.

Justin Renz: No, I think that’s fine.

Mike Raab: Laura?

Laura Chico: Thanks guys, okay. And then, if I could follow-up on one just to with respective to the legislation. I don’t think we’ve seen taxed on the bill yet, and I know you mentioned we’ve already had the can kicked on the road three times previously. I guess just on the off chance the bill does not progress, I’m just wondering if you could kind of walk through mechanistically what would actually happen if it were included in the bundle. I guess, I’m trying to work through the scenario of potential impact during a transition. Yes, thanks if there is any color that you could provide.

Mike Raab: Sure. And to see the tax to the bill you can go to Buddy Carter’s website, congressman from Georgia and the bill is there. Well, as it relates to the bundle, it’s would end up being January 1st, ’25, as it goes in annual to middle year on a two year to half a period. Like other drugs has gone and so maybe like since on possible. They collect the data from that two year period and then the following year day increased our base rate based upon the calculation on those data bit collected to increase the base rate to cover it the cost associated with anything going into the bundle. I think what makes these all along they’re so unique is that they are not given during a provision of dialysis, if you recall or as we talk that in fact you’re not allowed to eat when you’re on dialysis.

And certainly our package and certain others say yes to take your drugs while you have food, right, whether it’s a meal or a snack in case of binders and for us it’s one small pill before at breakfast and whether it’s dinner or lunch your next largest meal. So, it makes it a vexing issue for providers to actually accomplish what they need to and they’re not going to be giving these drugs during the provision of the dialysis services.

Laura Chico: That’s very helpful, Mike. Last question I have, and back in the queue. In terms of ATM utilization, I think there 11 million generated this quarter. Could you just comment on kind of appetite for further use of the ATM. Thanks, very much?