CorMedix Inc. Wells Fargo 21st Annual Healthcare Conference

Afternoon, everyone. I'm Rahul Sood, managing director in the healthcare investment banking group at Wells Fargo. I'm joined on the stage today with Joseph Todisco, Chairman and CEO of CorMedix.

Joe, welcome. Thank you. Good to be here, Rahul.

Thank you. Thank you for being here. So why don't we get started? CorMedix has seen a lot of change over the past couple of years.

Take us through the journey, where CorMedix was in 2024, where CorMedix is today.

Well, look, I joined CorMedix in 2022, right? We've changed significantly since then. I joined a company that was pre-commercial, single product company, resolving a CRL, right? But had a great product in DefenCath with a really strong clinical proposition, and a really unique reimbursement, right? This TDAPA reimbursement that can present some challenges. In 2024, we had gotten the product approved in late 2023, but from where we were in 2024, we were building out launch infrastructure, we were starting to commercialize the product. Only one of three TDAPA launches at the time. I think what we made, it was one of the first that was really truly successful over that two-year period of time where you have separate payment.

We leveraged that and that cash flow into the acquisition of Melinta and really built the company into a diversified, specialty pharmaceutical company with a large deployment in institutional settings of care, right? That being hospitals, infusion clinics. We'll be entering into the hematology oncology space, hopefully with the approval of REZZAYO for an expanded indication next year. But really built a more robust, diversified platform.

Great. You touched upon this, that you acquired Melinta. Your portfolio's gone from single product to eight marketed products today, sold in more than 500 hospitals, infusion centers and clinics. How would you describe the commercial platform that you built, and what does it let you do next?

Look, it's big and it's scalable, right? In terms of we are deployed in the inpatient space, in the hospital space. We have touchpoints into infusion clinics, right? We're building touchpoints into the hematology oncology bone marrow transplant center space. There's a lot of commonality amongst what I call institutional settings of care, particularly for injectable drugs, in terms of how they're sold, how they're priced, how they're marketed, where you really don't need to necessarily focus just on a single therapeutic area to obtain some types of synergy. Look, we're focused on, one, executing on the assets we have in that space, but also looking to layer on additional assets that are synergistic with that field deployment.

Got it. You touched upon Melinta. That acquisition closed last year.

So you've gone past the one-year anniversary mark on it. Can you review the rationale for that transaction and how do you see that business positioned today for success?

Sure. You're right, we just hit the one-year anniversary last week of the Melinta acquisition. For us, it was really transformational. We were, as I said, in the midst of the first year of our TDAPA, driving decent cash flow, but knowing that we have this reimbursement transition and kind of wanting to parlay that cash flow and success into a more diversifying transaction. Melinta gave us that, right? It gave us what I'll call a stable-ish base business of institutionally utilized anti-infective drugs like VABOMERE and MINOCIN, as well as a potential future growth asset with REZZAYO, right? Which we've just read out the phase III data for prophylaxis of fungal infections. So for us, I really see it as transforming the business and putting us in a much stronger position today than we were 12 months ago.

Got it. Let's switch gears onto DefenCath. You touched upon the TDAPA piece. That's something quite unique. Not a whole lot of drugs have gone through that reimbursement mechanism. You guys have done it quite successfully. DefenCath has been a driver for the business over the past couple of years. Can you discuss the shift now that you're going in this new reimbursement dynamic, and where do you see the business going over the next 12 to 18 months with that?

Yeah. The shift that takes place is under TDAPA, this transitional drug add-on payment, you get 24 months or two years of separate payment, buy and bill reimbursement, and then it transitions into three years of a bundled add-on. In the ESRD space, the dialysis operators essentially get a fixed amount of money, right? For all drugs and services used in administering dialysis and then for innovative drugs, they give an add-on payment for a period of time. We are working through that transition right now, and our goal when our TDAPA ended on June 30th, and we moved into July 1, was to essentially preserve patient volumes. We had built up a good, in our mind, patient run rate, and we decided to really discount the price in order to make it more cost neutral for the dialysis operators to maintain patients on therapy.

Our expectation is that in 2027, the bundled add-on will go up from what it was calculated for the third and fourth quarter, and we will be able to get a little bit more price appreciation, or sorry, a little more profitability.