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

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Justin Renz: Yes, thank you Matt. So, we’re we like to add we anticipate additional incremental $20 million the combined SG&A spend will go up from additional quite supply spend spending in this quarter and going on. That will be the incremental cost. Of course, from these not giving you the market I’m generating rather that would be offset by the PDUFA and is having a — we’ve gotten into an incremental $20 million quarter respective of.

Matthew Kaplan: Okay, thanks. Thanks, again.

Mike Raab: Thanks, Matt.

Operator: Right, thank you. [Operator Instructions] And the next question comes from Peyton Bohnsack with TD Cowen.

Peyton Bohnsack: Hi, guys. Thanks for taking our questions. I guess a little more on the PDUFA that you mentioned. So, if I’m assuming you’ve to apply for this. It’s my assumption that you guys would apply for this if it wasn’t put in the bundle however — unless in there maybe.

Mike Raab: Yes. I mean, to whatever the process is to get those data collected, we would certainly participate in that.

Peyton Bohnsack: All right, got you. And then, I guess it’s kind of like a follow-up. How have kind of discussion been going for other areas like to sort of Europe. Have you begun to look forward at those and if you have any timelines, that’d be great.

Mike Raab: Yes, so we had ongoing discussions in all the partnered territories, whether it’s IBS-C and Japan, and Europe, rest of world. Those conversations continue. Some there is better trajectory. And others, no specific timeline that I can give you in terms of when anything like that would be finalized.

Peyton Bohnsack: Yes. And I guess, just like one final one for me. Seeing how you guys are pretty deep into the IBSRELA launch now and the vote is probably going to get approved and then launched. Could you maybe talk about your long-term PND or an internal R&D strategy, would you guys restart your earlier stage pipeline so we could be looking to like something?

Mike Raab: Yes, I mean it’s a great question at least as we’ve said. There is a couple of programs that are sort of laying shallow at this point towards these metabolic acidosis, the hyperkalemia program to speak of two that will sufficient capital, obviously looking at those and restarting those would be a prudent thing to do. I think what we’re also demonstrating Peyton was what we’ve done with IBSRELA and confidence we’ll demonstrate with XPHOZAH, is an extraordinarily powerful commercial organization. And that should be the partner of choice for new and upcoming drugs in IBS and new and upcoming drugs in dialysis and renal. So, we’ll continue looking across multiple ways of strengthening our pipeline and as we get to a place where we have strong enough balance sheet to do that.

Peyton Bohnsack: Great, thank you very much. I appreciate all the color.

Mike Raab: Thank you, Peyton.

Operator: Thank you. And this concludes our question-and-answer session. I’d like to return the conference back over to President and CEO Mike Raab for any closing comments.

Mike Raab: Thank you everyone for joining us this morning. I look forward to providing you with further updates in the weeks and months ahead. We have a number of milestones that I look forward to sharing including an approval of XPHOZAH in October and continued growth of IBSRELA. With that, we can close the call. Thank you operator.

Operator: Thank you. The conference have concluded. Thank you for attending today’s presentation, may all disconnect.

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