Good day, and welcome to the CorMedix Inc. Second Quarter 2024 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded. I'd now like to turn the conference over to your host today, Daniel Ferry. Please go ahead.

Good morning, and welcome to the CorMedix second quarter 2024 earnings conference call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix and he is joined by Dr. Matt David, Executive Vice President and CFO; Beth Zelnick Kaufman, EVP and Chief Legal Officer; Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer; and Erin Mistry, EVP and Chief Commercial Officer. Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are statements other than statements of historical fact regarding management's expectations, beliefs, goals and plans about the company's prospects and future financial position. Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risks and uncertainties described in greater detail in CorMedix's filings with the SEC, which are available free of charge at the SEC's website or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in these forward-looking statements. Investors should not place undue reliance on these statements. CorMedix does not intend to update these forward-looking statements, except as required by law. At this time, it's now my pleasure to turn the call over to Joe Todisco, Chief Executive Officer of CorMedix. Joe, please go ahead.

Thanks, Dan. Good morning, everyone, and thank you for joining us on this call. As we reach the midpoint in the financial year, I'm incredibly pleased with the progress the company has made related to the launch of DefenCath, and I'm optimistic about the sales trajectory we have seen through only the first few weeks of the outpatient launch. CorMedix commenced the inpatient launch of DefenCath on April 15, and commenced the outpatient launch during the first week of July, just after the close of the second quarter. The commercial launch milestone marks the culmination of the efforts of countless individuals, including CorMedix employees, contractors and consultants, who worked tirelessly over the last decade to bring this innovative drug product to patients in need. I'm extremely proud of this achievement, and I'm excited about the potential for DefenCath utilization and the resulting impact DefenCath can have on patient infection rates. Though the inpatient launch of DefenCath commenced on April 15, as we communicated earlier, the inpatient sales cycle is relatively long. And our initial efforts have been focused on engaging customers to champion DefenCath for P&T formulary review at hospitals and health systems. In this regard, we have seen significant progress in terms of meetings scheduled over the upcoming months. And from the handful of meetings that have already occurred, we are pleased with the majority of outcomes. We do expect a lag between P&T formulary approval and facility ordering, and we may have more -- and we have many more P&T meetings scheduled between now and the end of this calendar year. In light of this long sales cycle, second quarter sales were expectedly modest, consisting primarily of trade stocking for inpatient facilities. We expect inpatient sales to begin to ramp in the fourth quarter as DefenCath is reviewed,…

Thanks, Joe, and good morning, everyone. I'm pleased to be here today to provide an overview of our second quarter 2024 financial results as well as an update on CorMedix's cash position. The company has filed its quarterly report on Form 10-Q for the quarter ended June 30, 2024. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our second quarter of 2024 financial results, our net revenue for the second quarter of 2024 amounted to $0.8 million. This marks the first time that CorMedix has reported revenue from the U.S. distribution of DefenCath. Our net loss was approximately $14.2 million or $0.25 per share compared with a net loss of $11.3 million or $0.25 per share in the second quarter of 2023. The higher net loss recognized in 2024 compared with 2023 was driven by an increase in SG&A expenses versus the second quarter of 2023 in anticipation of commercial launch. Operating expenses in the second quarter of 2024 increased approximately 32% to $15.6 million compared with $11.8 million in the second quarter of 2023. R&D expense decreased by approximately 86% to $0.7 million, driven by the approval of DefenCath. As a result of the post-FDA approval of commercial operations, costs related to medical affairs and certain personnel expenses that supported R&D efforts prior to the FDA approval of DefenCath have been recognized in sales and marketing or G&A expense. SG&A expense increased approximately 113% to $14.9 million in the second quarter of 2024 compared with $7 million in the second quarter of 2023. CorMedix is now reporting sales and marketing expense and general and administrative or G&A expense as separate line items. On an apples-to-apples basis, sales and marketing expense increased 127% to $7.4…

Thanks, Matt. CorMedix is executing well on our key objectives and is hopeful to provide more substantive updates on sales progress and commercial uptake at DefenCath in our next quarterly call in November. I appreciate everyone's continued support and CorMedix, and I'm happy to open the line for questions.

[Operator Instructions] This morning's first question comes from Gregory Renza with RBC Capital Markets.

Hi Joe, and team. It's Anish on for Greg. Congrats on the progress this quarter and thanks for taking our questions. Just a couple from us. First, just when you think about CLABSI, how do readmission rates for CLABSI, compared to CRBSI? And how would you think about gearing your education and marketing strategy for DefenCath accordingly? And second, on the granted pass-through status for DefenCath, how can this be leveraged to facilitate uptake? Thanks so much.

All right. Thanks, Anish. So I think what you're asking is the difference between a CLABSI and the CRBSI, if I'm not mistaken, and kind of how that may show differently in the data. So I'm going to let Liz, just from a clinical definition standpoint, kind of chime in on the difference between these two. But I think why that's relevant is from a TPN standpoint, we are designing the study for CLABSI, right, versus CRBSI. And I think, the way to somewhat look at it before Liz gives the definition is that, I guess, all CRBSIs are CLABSIs, but all CLABSIs are not CRBSIs, right? CLABSI is a little bit of a broader determination. But go ahead, Liz.

Yes, exactly. So like Joe said, CRBSI is a subset of the larger CLABSI. And CRBSIs need clinical correlations. So signs of sepsis or positive peripheral blood cultures in the absence of an obvious source other than the CVC. And CLABSI, which is your more general term is a primary bloodstream infection in a patient that has had a central line within the 48-hour period before these symptoms develop. So you can think of CLABSI as an umbrella. And then there's a subset of types of infections after that that require different blood cultures, or other clinical correlation to confirm them.

Thanks, Liz. And I think, to get to your question on pass-through status. So what pass-through status allows is for the providers that install catheters, and utilize DefenCath during that catheter installation to bill for the product on a buy-and-bill basis, similar to any other kind of Medicare B product, right? So that's an ASP+. It's a small part of the segment, but I think that it's meaningful, because it is the first time the patient is getting the catheter, right? So, we want to protect the line from the start. It's the opportunity utilize DefenCath from the beginning of each patient. So that's essentially why we see it as meaningful, even though it's a small part of the population.

Great. Thanks I appreciate all the color.

No problem.

Thank you. And the next question comes from Jason Butler with Citizens JMP.

Hi thanks for taking the questions and congrats on the progress. First one, just in terms of the run rate for 3Q, how should we think about the $5.2 million, and growth beyond that? I guess what I'm asking is, do you expect there to be essentially time taken now for those initial centers, to work through those initial orders? Or should we see continued orders beyond the $5.2 million? And then, can you give us a sense of how many centers in the outpatient setting you're actually seeing, pull-through from? Thanks.

Thanks, Jason. So that's a - yes, from - on the $5.2 million, I think what I'm comfortable saying is that we've seen consistent orders repeatedly over the last four weeks. And we're seeing those at the clinic level, right, with repeats and restocking of similar sized orders. So that gives us the impression of those clinics are pulling that through into the patients, which is why I'm comfortable saying that we don't believe there's much, if any, trade stocking in that third quarter number. So I hate to guide you what the back part of the quarter is going to look like and all of the crystal ball. But I feel good about what we've seen, from those first four weeks, four and a half weeks of shipments. In terms of how many centers, again, I prefer not give an exact number, it is several hundred that we are currently shipping to.

Okay. Great. I think - could you just walk us through the comments that Matt gave about hitting breakeven by the end of '24 again? And what assumptions we would need to consider to get to breakeven by the end of '24? Thanks.

Yes. Look, I think you've got a good sense for what our operating expense is. We've guided at $15 million to $18 million OpEx. I think we came in at the low point of that for this quarter. Maybe it ticks up a little bit as we get to the back part of the year. I think we've guided you on future clinical costs, which really don't kick in until next year and the year after. And even if you overlay those on top of each other, right, or - I think we're designing fairly modestly priced clinical programs that at peak, maybe $3 million to $4 million in a quarter, right? Probably in late '25 or '26. So the amount of revenue or gross margin needed to cover the OpEx, I think gives you a sense of where we need to be running at. So you've seen our first kind of five weeks of shipments. I think it's conceivable that if we - and this is all with small and midsized dialysis operators. So if and when, hopefully, we do onboard some larger accounts and we see increased volume move in the back part of the year. I think that breakeven EBITDA is certainly achievable before the end of the year.

Great. Thanks for taking the questions.

Thank you. And the next question comes from Les Sulewski with Truist.

Good morning. Thanks for taking my questions. Can you just talk about the progress on conversations on the dialysis operators, particularly the larger ones? And I guess, separately, what percentage of the market has your sales team touched? And is there are any reasons you perhaps are hearing any sort of hesitation on adoption? Can you speak to those? And then I have two follow-ups?

All right. Thanks, Les. So obviously, we've - I think we've been pretty candid that we're in discussions with one of the Top two, right? Certainly, I know we talked about that. On the last call, I'd say that, that remains the case. I do feel like we're pretty close. And I think what I would comment on timing, which is kind of what I think you're asking is that when you're dealing with larger organizations with bunch of multiple functional areas that need to weigh in on a contract. That process has maybe taking a little longer than I expected. So I'm still optimistic about our ability to move forward, and the signals that I've received have been very positive. On one of the other LDOs, I do think they're taking a wait-and-see approach, and we'll be reengaging later in the year. In terms of percent of the market touched, right? A lot of the decision-making, whether it's an SBO, MDO or LDL that comes from the top down, right? So I'd say we're touching - of the top 20 accounts that represent 99% of dialysis, we're touching them all, right? So the field team right now is focused on probably smaller to midsized accounts and pull-through, as well as the inpatient formulary process, and that's where we want them deployed. There was a third part of your question was - I apologize I'm...

Just if you're hearing any sort of hesitation on adoption?

Look, as I said, I think some are waiting to see what others are doing, right? I think you have some smaller operators that may be less familiar with - had a process TDAPA or reimbursement, and we're trying to educate on that. So that it's a little bit more familiar. It is still a relatively new reimbursement platform. It's only a couple of years and does change, right, even TDAPA change last year. So there is some education that we are doing with the smaller - certainly the smaller operators on how to process reimbursement.

That's helpful. On the $5.2 million. Can you speak to perhaps the weekly progression of that? And then the 95% pull-through rate to the clinics, do you have an indication what percentage of that was utilization?

Look, because we're - I'll address the second question first. I think because we're shipping to a lot of these customers direct to clinic, which is why we're getting such good data on where it's going, I'd say we're not getting inventory on hand statements per se. But we are seeing repeat orders from similar clinics, so it gives us confidence that it's being utilized in the patients. I'm sorry, what was the first part of the question, Les?

The weekly progression?

Weekly progressions. Slightly somewhat consistent, right? I'd say it's been fairly consistent. I think there was initial, I'll say, patient suite, right, patient identification that customers did, started moving patients on. So, I'm hopeful that we'll see, as we move through the end of this quarter, next quarter, another, let's say, patient suite where we adopt, or they look to convert additional patients.

It sounds like it's probably a good proxy, for how the rest of the quarter will line up.

Yes. I hate to guide you that way, Les. Obviously, I said I don't have a crystal ball. I think Greg or Jason made ask the same thing. I feel good with the revenue run rate that we're seeing. I think that's how I'd describe it.

That's fair. Thanks Joe. And great detailed color on the pipeline. It's very helpful. Maybe a follow-up to that. It appears there's some costs involved. How do you intend to fund these studies, not much in terms of cost, but just maybe talk about the funding there. And then just quickly expect the time line on the TPN enrollment. And like, could we expect interim top line prior to '27, '28? Thank you.

Yes. So I'll let Liz get into the kind of the clinical time line in a second. But I think you're asking about its financing, Les. And I want to kind of comment on a couple of things, and make sure that we're clear. So, I continue to believe we don't need to do any type of, let's say, large dilutive financing at this time, right? We've got a revenue run rate that I feel pretty good about. Just even five weeks into starting shipments that's offsetting a large amount of operating expenses. And I walked through with Jason kind of you've got these clinical budgets for the four programs relatively modest. And even if you overlay them right on top of each other at peak, I feel that with cash on hand, operating cash flow, we have the ability to fund these studies without any type of, call it, large financing. But that said, we do have the ATM facility in place, which gives us the ability to raise small amounts of money at the market price. We used a little bit of it last quarter when the stock price was up on some higher volume days. We could continue, to utilize the ATM to supplement our cash flow from operations, but that's currently how I'm thinking about the trajectory of the business and funding additional growth.

And the time lines?

Liz, go ahead.

Sure. Yes. Thanks, Les. So the study is a Phase 3 study that has 12 months of intervention in it. We're looking forward to kicking it off as soon as we get feedback from FDA or clear that 30-day statutory hold. We have a lot of enthusiasm from TPN docs as this remains a very critical unmet need in this space. So I don't want to overpromise for enrollment, but we feel pretty positive that we'll have up to 25 sites in the U.S. that are actively engaged and interested to participate. We don't have a planned interim analysis in terms of a readout, but I certainly expect that we'll see something before '28.

Great. Thank you

Yes.

Thank you. And the next question comes from John Juco with Needham & Company.

Hi, good morning. This is John on for Serge today. Congrats on the initial launch report and thanks for taking our questions. And first, can you just touch on the process for DefenCath trial and adoption across the inpatient and outpatient segments? And any notable differences between those two processes? And then second, regarding the TDAPA reimbursement process that's in place, is this kind of a seamless and easily operating at this time? And is this something that most operators are familiar with?

Yes. I'll take the second question first, and then I'm going to pass the first question over to Liz. Look, in terms of TDAPA, I think I kind of hit on it before. It is a relatively new reimbursement mechanism in the last couple of years. I'd say a lot of the operators are familiar with it. But some - for some, it's still new when it's requiring some education. So all the systems are in place, right, for the government to process these claims. And so that's not an issue. It's just whether or not a dialysis operator has ever processed TDAPA reimbursement before, and needs a little bit of assistance in understanding, how to go about doing that. Now, Liz, go ahead in terms of inpatient versus outpatient kind of process.

Sure. Yes. So they definitely are different processes, right? So within an institution or a hospital setting, you've got a ton of varying factors here, right, system size, operations infrastructure, capacity to adapt internal demand for the product, which is what the field team is very focused on. They're looking at safety data, they're engaging with us. And then you've got to get to P&T, right? And then after you get to P&T, if the product is approved, there is a process in terms of pulling it through, to build it out in your EMR, builds out your charge descriptions and master build, get the pharmacy up to speed with dispensing and stocking, right? So it can be really efficient in certain institutions, and it can take many, many months depending on the bureaucracy you're dealing with in an institution. On the outpatient side, right, it is very much driven by the physicians, but there is - it's an onerous and I would say, rigorous operational out-roll for the clinics to do, right? These are already sometimes understaffed, working really hard and you've got to do policies, procedures, protocols order sets to get everything up to speed to roll this out nationwide in a clinic or even a small center, right? So there's a lot of work that goes into it. I think the uptake on an outpatient side can be a little bit faster for sure, especially when you're looking at a small or medium-sized deal. But these are not overnight processes, and it takes a lot of time. They've got to train all of their staff, and we're a new innovative product, right? So there's a lot of education that goes into it as well. So I would say from an expectation standpoint, I would say it that inpatient is going to take longer to adopt and pull through. And on the outpatient side, we're hoping for much faster adoption, and that's what the field team is focused on, on educating our clients and customers for.

Thanks Liz. Great. Thanks for the color

Thanks, John

Thank you. And now I'd like to turn the floor to Daniel Ferry, who will facilitate written questions, which have been submitted.

Thank you, operator. Joe, we have a few written questions from the audience. How is the contract going with the previously announced top-tier midsized dialysis provider? Can you provide us any color on this contract's contribution to sales? And can you disclose who it is?

Okay. Thanks, Dan. So I guess I'll start by saying I couldn't be happier with the relationship or what we're seeing from a kind of patient and product uptake standpoint. We don't intend to provide any kind of customer-specific sales breakdown at this time. But I will say, as the largest of our customers in terms of clinics, they're also currently the largest in terms of DefenCath utilization. So they are a big driver behind our initial uptake, but we do certainly have material sales to other kind of smaller to midsize customers as well. On the publicity front, I would say that they're a privately held organization that has asked us for the time being to not utilize their name and publications and focus on implementation and execution. So to that extent, we're respecting the request of our currently largest customer and focused on building the business. As I mentioned, we do have other - a couple of other small dialysis organizations that are under contract that we didn't separately announce for similar reasons. So, we're happy with those relationships as well.

Okay. Great. Another one here. You commented today about Medicare Advantage being a sizable and growing group of Medicare patients. Can you explain how, is this different from traditional Medicare for DefenCath? Also, how is it reimbursed - reimbursement handle today if a dialysis provider uses DefenCath in a Medicare Advantage patient? And a follow-up here, what did you mean that United expects to provide comparable TDAPA reimbursement? And will they always provide that?

Okay. Thanks, Dan. I'm sure that was a lot for you to consolidate. I'm going to try and break them down into pieces. So I guess, first, Medicare Advantage in relation to traditional Medicare, it's essentially, right, it's a privatization of Medicare, where managed care providers like United, Humana, they assume risk for all costs associated with a Medicare patient in exchange for premiums and a fixed amount from the government. The MA plan then essentially controls drug formulary and kind of manages treatment similar to private commercial insurance. So they're the ones that are on the hook for all the costs and the risk. Now with the TDAPA, historically, whether or not the MA plan paid at TDAPA, would depend on what agreement was in place, between the provider and that MA plan, and whether or not there were new innovations covered under that agreement. Which was why we're happy that United has communicated a willingness to pay TDAPA for DefenCath beginning on September 1. We think that's incredibly meaningful. Now in terms of, I guess, how those payments may track or change over time. I think that's the primary reason why we want to run this real-world evidence study and our biggest opportunity from a reimbursement standpoint. So since the MA plans, as I said, are on the hook for all of these medical costs for the patients. They're the ones that are going to bear the brunt of the downstream costs associated with getting a CRBSI. So, if you think about it as if CRBSI can cost upwards of $60,000 a year, and then you add other downstream costs that gets over - can get over $100,000. We've really seen opportunity here to generate real-world data during the TDAPA period, and hope to utilize it to negotiate, let's say, longer term more sustainable reimbursement with the MA plans. And from a macro level, we expect the majority of ESRD patients to be shifting into these MA plans over the next five years.

Great. Thanks, Joe. Operator, this concludes the question-and-answer session. You may now close the call.

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.