CorMedix Inc. (NASDAQ:CRMD) Q4 2022 Earnings Call Transcript

Joe Todisco: Thanks Joon. Well, look, I mean, if we found ourselves, I guess, with an approval earlier than what maybe had been expected previously, certainly it’s still going to take a couple of months, right for us to ramp up with field force training. I would say we do feel we’re in a good position from an inventory standpoint, or we’ll be in a good position from an inventory standpoint, but it’s certainly going to have to be a soft launch into a rolling, more robust launch after a couple of months. On the inpatient side, Erin can maybe speak to it, right. There’s going to be a process of getting the inpatient institutions right through P&T, getting the product on formulary. And on the outpatient side, we’re not going to know our reimbursement for at least six months. So there’s going to have to be a little bit of slow ramp in the beginning while that outpatient reimbursement gets sorted out.

Joon Lee: Thank you.

Operator: Thank you. I will now turn the call over to Dan Ferry for written questions. Dan?

Dan Ferry: Thank you, operator. Joe, I have a few written questions from the audience. The first one, and, and I think we touched on this a little bit earlier, is if and when the NDA is resubmitted, will you announce at the time of resubmission or once the NDA has been accepted?

Joe Todisco: Thanks, Dan. It would be my intention to announce, once we resubmit and then again likely communicate more if and when the application is accepted for filing and we know if it’s a Class 1 or Class 2 resubmission, that’s my current intention.

Dan Ferry: Okay. Thanks Joe. And another one, this is a two part question that you just touched on a bit earlier is, are there any updates that can be shared on your commercial efforts in the inpatient segment and the outpatient segment? And then the follow up there would be, as you think about the inpatient launch, what are the main challenges as you see that must be navigated during the lead up to and through commercial introduction?

Joe Todisco: Okay. Thanks Dan. I’m going to give Erin an opportunity to comment on the activities that have been going on, on the outpatient side and kind of how we’re navigating this right now. Erin?

Erin Mistry: Sure. Thanks Dan. So the progress from the inpatient perspective, I’ll take it that one first is we’ve been building relationships with key health systems, working through what’s required for the formulary package itself, budget impact models, cost offset models, those types of things. We’ve made some big hires recently internally within the organization to help make that progress move that progress forward. And then we’re also looking at potential strategic partnerships to manage the patient population. On the outpatient side, we are working with €“ continuing to work with dialysis organizations and with policymakers at both CMS and politically. And we are going to continue those efforts in hopes to gain separate reimbursement on the outpatient side.

And as Joe said, that timing is simultaneous as we’re launching the inpatient segment. But I think that the biggest thing here as Joe mentioned earlier, the reimbursement on the inpatient segment has taken off the table, right. We were able because of our regulatory designations to go through an alternative NTAP pathway where we now have that reimbursement and make those conversations much easier.

Dan Ferry: Excellent. Thanks, Erin. So Joe, have a few more here. What is your current thinking on building the field force, is CorMedix going to wait until around the time of approval to avoid taking on overhead at risk?