CorMedix Q3 2024 Earnings Report

CorMedix EPS Results

• Actual EPS: -$0.05
• Consensus EPS: -$0.10
• Beat/Miss: Beat by +$0.05
• One Year Ago EPS: -$0.17

CorMedix Revenue Results

• Actual Revenue: $11.46 million
• Expected Revenue: $11.00 million
• Beat/Miss: Beat by +$460.00 thousand
• YoY Revenue Growth: N/A

CorMedix Announcement Details

• Quarter: Q3 2024
• Date: 10/30/2024
• Time: Before Market Opens
• Conference Call Date: Wednesday, October 30, 2024
• Conference Call Time: 8:30AM ET

CorMedix (NASDAQ:CRMD). is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to reduce inflammation and prevent infection in critically and chronically ill patient populations. The company’s lead product candidate, Neutrolin, is a catheter lock solution that combines taurolidine, heparin and citrate to prevent catheter-related bloodstream infections (CRBSIs) in patients undergoing hemodialysis. Neutrolin has received market authorization in the European Union under the CE Mark and is positioned to address a significant unmet medical need for infection prevention in dialysis centers.

In addition to its lead asset, CorMedix is advancing a biochemical portfolio aimed at mitigating complications associated with peritoneal dialysis and other high-risk procedures. The company is engaged in clinical and regulatory activities designed to support product labeling updates and broader patient access. Collaborative partnerships with dialysis providers and distributors help position CorMedix to deliver its therapies into established treatment settings.

Founded in the mid-2000s and headquartered in Piscataway, New Jersey, CorMedix operates with a lean corporate structure that leverages external manufacturing and distribution networks. The company’s senior management team is led by President and Chief Executive Officer Craig Fraser, who brings more than 30 years of experience in the biopharmaceutical industry. CorMedix continues to pursue regulatory milestones and commercial arrangements that aim to expand its reach across North America, Europe and select emerging markets.

CorMedix Q3 2024 Earnings Call Transcript

Key Takeaways

• Q3 net revenue of $11.5 million exceeded Street consensus, driven primarily by initial anchor customer U.S. Renal’s rapid Fencat implementation.
• Signed agreements with two midsized and one large dialysis operator covering roughly 60% of U.S. clinics, with purchases expected to begin before year-end and drive a Q4 EBITDA positive result.
• Fourth-quarter revenue carries material variability due to the timing and scale of orders from the large dialysis operator and newly announced midsized customers.
• Strong liquidity with $46 million in cash plus $12.4 million of ATM proceeds, projected to fund operations for at least 12 months and support a Q4 EBITDA positive outcome.
• Advancing the pipeline with a planned mid-November FDA submission for the adult TPN protocol targeting late 2027/28 approval and launching real-world, pediatric and expanded-access studies to support label expansion.

Presentation

[Operator]

Good day, and welcome to the CorMedix Inc. Third Quarter 2024 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead.

[Dan Ferry, Managing Director at LifeSci Advisors]

Thanks, Operator. Good morning, and welcome to the CorMedix Third Quarter 2024 Earnings Conference Call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix. 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.

[Dan Ferry, Managing Director at LifeSci Advisors]

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 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, and 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 is now my pleasure to turn the call over to Joe Todisco, Chief Executive Officer of CorMedix. Joe, please go ahead.

[Joe Todisco, CEO at CorMedix Inc]

Thanks, Dan. Good morning, everyone, and thank you for joining the call. As we approach the end of our first calendar year of commercial launch at DefenCath, I'm incredibly proud of the team's efforts and pleased with the commercial results thus far. The third quarter marks the first full quarter of product shipments at DefenCath, as well as the first quarter of outpatient product utilization. Our net revenue for the third quarter of $11.5 million exceeded street consensus and was largely driven by our initial anchor customer, US Renal, which has done an exceptional job with DefenCath implementation within its clinics. We recently announced new agreements with two mid-size dialysis operators and one large-scale operator, which, combined with our existing customers, will provide patients access to DefenCath at roughly 60% of dialysis clinics in the U.S.

[Joe Todisco, CEO at CorMedix Inc]

We are currently working diligently with our new partners to operationalize those agreements and currently expect purchases to commence for all three before the end of the fourth quarter. While we have not issued revenue guidance for the fourth quarter, based upon our current forecast, we do expect to be EBITDA positive for the fourth quarter. With respect to guidance, there is a wide potential variability for fourth quarter revenue, driven by the timing and scale of purchases by our LDO customer, as well as the scale of purchases by our newly announced mid-size customers. DefenCath, for the most part, is being protocolized by the outpatient customers that adopt the product, meaning they are establishing criteria for patients in their system for which DefenCath is appropriate and then implementing protocols based on those criteria.

[Joe Todisco, CEO at CorMedix Inc]

This requires a significant pre-implementation effort with each customer to establish protocols, order sets, and conduct training on an enterprise level, and in the case of our LDO customer, requires implementation on a much larger scale to allow a rollout at over 2,000 clinics. The upside of having our drug protocolized in this manner is that once a customer goes live, we expect the patient conversion ramp to move fairly quickly. The downside is that setup can take anywhere from several weeks to a few months. Currently, we are expecting our LDO customer to begin ordering in December, but a couple of weeks' movement in either direction from a customer of this scale would obviously have a material impact on our fourth quarter revenue. For our new MDO customers, we expect orders to begin in November.

[Joe Todisco, CEO at CorMedix Inc]

With respect to our inpatient launch activities, we have made significant progress in terms of building DefenCath champions within hospitals and health systems and scheduling P&T meetings with those institutions. A large number of P&T meetings occurred in the third quarter, and we are in the process of fielding questions and providing additional information required for a formal decision. These P&T committee discussions require both a comprehensive review and collaboration across multiple stakeholders, including clinical and financial, within the health system. To that extent, we expect the inpatient uptake process to be longer and the ramp to be more consistent with traditional inpatient launches in comparison to the more rapid uptake we have seen on the outpatient side.

[Joe Todisco, CEO at CorMedix Inc]

We have started to see some utilization in the handful of hospitals that have completed P&T review early and added DefenCath to formulary, and we are optimistic to build on that progress in 2025 as we continue our field efforts with DefenCath advocates. Focusing now on our clinical developments, we announced in the second quarter that we received supportive feedback from FDA related to our proposed clinical pathway for adult total parenteral nutrition, or TPN. Since then, we have received FDA feedback and conducted extensive market research and clinical feasibility studies, and accordingly, we are refining the clinical protocol and anticipate submitting it to FDA by mid-November to align with our plans to operationalize the study in the first half of 2025.

[Joe Todisco, CEO at CorMedix Inc]

The company's goal for TPN is to obtain FDA approval for an expanded use of our taurolidine and heparin catheter lock solution in the late 2027-2028 timeframe, and we estimate annual peak sales potential in this indication to be in the range of $150-$200 million. We will provide investors with updates on progress as we move forward. From a clinical budget standpoint, we anticipate the study to cost between $10 and $12 million, with the majority of expense spanning the 2025 and 2026 calendar years. During our previous earnings call, we also announced three additional clinical initiatives, all expected to commence in the 2024 or early 2025 timeframe. The most meaningful of the three, from a data value standpoint, is our real-world evidence study that we will run in cooperation with our study partner, US Renal Care.

[Joe Todisco, CEO at CorMedix Inc]

Our hope with this study, in which we expect to evaluate outcomes of roughly 2,000 patients over 24 months at a cost of less than $1 million a year, would be to generate real-world evidence around the impact of DefenCath utilization on cost of patient care, infection rates, hospitalizations, mortality, and multiple other metrics such as lost chair time and antibiotic use. Ultimately, we would intend to utilize this data in our post-TDAPA period to negotiate future sustainable reimbursement for Medicare Advantage plans and other value-based care contracting entities. Data collection for this study has already commenced. Simultaneously with our adult TPN and real-world evidence studies, we will also be commencing a study in pediatric hemodialysis.

[Joe Todisco, CEO at CorMedix Inc]

This will be a relatively small study spread over several years, as we expect patient enrollment to be a challenge given an extremely small patient population and the need for very personalized protocols for these ultra-vulnerable patients. This pediatric study is a post-marketing requirement under the Pediatric Research Equity Act by the FDA, and we have FDA's concurrence on a final study protocol. We have plans to begin patient enrollment in early 2025, and we expect the study to cost between $4 million and $6 million spread over five years. Lastly, in addition to our other clinical initiatives, we plan to commence an expanded access program for high-risk populations, including but not limited to pediatric TPN, peritoneal dialysis patients with refractory peritonitis, and neutropenic oncology patients utilizing a CVC. These high-risk patients are those that have exhausted other infection prevention methods and, unfortunately, remain at significant risk for comorbidities and mortality.

[Joe Todisco, CEO at CorMedix Inc]

The cost for the expanded access program is expected to be less than $750,000 a year, primarily in the form of free product and distribution costs, and we expect to generate data that supports further label expansion and complements our adult TPN program. I would now like to turn the call over to Matt to discuss the company's third quarter financial results and financial position. Matt.

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

Thanks, Joe, and good morning, everyone. I am pleased to be here today to provide an overview of our third 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 September 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 third quarter of 2024 financial results, our net revenue for the third quarter of 2024 amounted to $11.5 million. As Joe indicated, this marks the first full quarter since DefenCath became commercially available this past spring. Our net loss was approximately $2.8 million, or $0.05 per share, compared with a loss of $9.7 million, or $0.17 per share, in the third quarter of 2023.

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

The smaller net loss recognized in 2024 compared with 2023 was driven by the gross profits associated with the net sales of DefenCath. Operating expenses in the third quarter of 2024 increased approximately 33% to $14.1 million, compared with $10.5 million in the third quarter of 2023. The increase was driven by higher selling and marketing and G&A expenses, offset by a decrease in R&D. CorMedix is now reporting selling and marketing expense and general and administrative expense as separate line items. On an apples-to-apples basis, selling and marketing expense increased 66% to $6.7 million in the third quarter of 2024, compared with $4.1 million in the third quarter of 2023. G&A expense increased 76% to $6.6 million in the third quarter of 2024 versus $3.7 million in the third quarter of 2023.

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

The increase in selling and marketing expense was attributable primarily to increased marketing efforts and new personnel, inclusive of our field sales organization, and support for the commercial launch of DefenCath. The increase in G&A expense was primarily due to increases in personnel costs in preparation for support activities related to the commercial launch, as well as certain expenses previously expensed as a component of R&D prior to FDA approval. R&D expense decreased by approximately 73% to $0.7 million, driven by the approval of DefenCath. As a result of the post-FDA approval 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 selling and marketing or G&A expense.

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

In addition, a portion of the costs related to the manufacturing of DefenCath, previously recognized in R&D, are now capitalized as a result of the FDA approval. With respect to our nine-month year-to-date 2024 financial results, total net revenue during the nine-month year-to-date of 2024 amounted to $12.3 million. Total operating expenses during nine-month year-to-date of 2024 amounted to $45.5 million, compared with $33.3 million in the first nine months of 2023, an increase of 37%. R&D expense decreased 80% to $2.2 million, driven primarily by the approval of DefenCath. Selling and marketing expense increased approximately 106% to $20.5 million, compared with the first nine months of 2023, and G&A expense increased approximately 83% to $22.9 million, compared with the comparable period in 2023. The increases in selling and marketing and G&A were driven primarily by new personnel and costs to support the commercial launch of DefenCath.

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

We recorded net cash used in operations during the nine-month year-to-date of 2024 of $45 million, compared with net cash used in operations of $27.7 million in the same period in 2023. The increase is primarily driven by an increase in trade receivables and inventories, offset by a smaller net increase of accrued expenses and accounts payable. The company has cash and cash equivalents of $46 million as of September 30, 2024. While we expect to begin to see cash collection from our accounts receivable in Q4, our cash position was supplemented in Q3 with approximately $12.4 million in net proceeds from ATM issuance. We believe our cash equivalents, short-term investments, and projected future operating cash flow give the company the ability to fund operations for at least 12 months.

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

Assuming we maintain our current trajectory of sales from existing outpatient accounts and see initial shipments to new accounts during Q4, we believe we can achieve positive EBITDA in the fourth quarter. I will now turn the call back to Joe for closing remarks. Joe?

[Joe Todisco, CEO at CorMedix Inc]

Thanks, Matt. CorMedix is executing well on our launch of DefenCath and focused on growing the business with existing customers, as well as expanding utilization of new ones. We're also actively working to expand the label for DefenCath beyond hemodialysis and beginning to scout for commercial-stage business development opportunities to expand our product portfolio beyond DefenCath. I appreciate everyone's continued support in CorMedix, and I'm happy to take questions.

[Operator]

We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. Our first question comes from Jason Butler with JMP. Please go ahead.

[Jason Butler, Managing Director of Biotechnology Equity Research at JMP]

Hi. Thanks for taking the questions and congrats on the quarter. I guess just a couple for me. Can you speak to the use that you're seeing today? To what extent is it being driven by individual doctors or centers' decision to use the product versus the overall institution already implementing SOPs? Second question, you've laid out reimbursement dynamics before for the outpatient setting, including the split between Medicare fee for service and Medicare Advantage. How do those broader population dynamics compare to what you're actually seeing during the launch? And then just lastly for me, can you speak to what you think about the trend for expenses, operating expenses in 4Q? Thanks.

[Joe Todisco, CEO at CorMedix Inc]

Okay. All right. Thanks, Jason. Appreciate the questions. So what I think we've seen most, or almost entirely, with the initial rollout has been a protocolization of the product, meaning it's more of a top-down-driven approach in the outpatient setting. We don't see as much of this being driven on a patient-by-patient or doctor-specific basis, right? So the centers are putting protocols in place. They're establishing criteria within their systems for who DefenCath is appropriate, and then they are implementing based on that criteria. And as I mentioned in the script, specifically with respect to our LDO customer, which we expect to follow the same pattern, right? The downside is that setup takes a couple of extra weeks leading in, but the upside is we expect patient conversion to move fairly quickly, right?

[Joe Todisco, CEO at CorMedix Inc]

We expect to see a similar type ramp to what we saw with our initial rollout with US Renal Care. So overall, we view that as a positive. Now, your question on reimbursement, I just want to make sure I understand. You were asking about what we're actually seeing in claims? Is that?

[Jason Butler, Managing Director of Biotechnology Equity Research at JMP]

Exactly. Yeah. Are you seeing that roughly similar balance between fee for service and the Med Advantage?

[Joe Todisco, CEO at CorMedix Inc]

Yeah. Well, look, claims data lags. So what we've seen with our initial customer rollout, I think, is patients or the facilities, rather, utilizing fee for service patients first, right, and then expanding use into other payers. So we are seeing claims that are being filed with Medicare Advantage, with Commercial, with Medicaid. So we are seeing, I'd say, a broad dispersion of claims. I'd say overall, though, in terms of you just looked at the aggregate number of patients that are getting DefenCath, I believe it's starting in the fee for service patients first and then expanding outward. And your third question, Jason, I apologize, was a—

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

How should we think about expenses? Yeah.

[Jason Butler, Managing Director of Biotechnology Equity Research at JMP]

Yeah.

[Joe Todisco, CEO at CorMedix Inc]

Yeah. Look, for the fourth quarter, I think we've guided to the year that's 15-18 by quarter. We've been on the low end of that range. We were below the range for this quarter. And I think we'll be somewhere in the 15-17 range for the fourth quarter is what I would expect. Matt, is that?

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

Thanks for taking the question.

[Joe Todisco, CEO at CorMedix Inc]

I just want to verify that with Matt. That's—

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

Yeah. I think that's probably fair, Joe. We've said to people we're going to begin to see things start to uptick related to R&D, but it's really the 2025, 2026 thing going forward.

[Joe Todisco, CEO at CorMedix Inc]

Yeah. Yeah. Not till Q1.

[Operator]

The next question comes from Gregory Renza with RBC Capital. Please go ahead.

[Gregory Renza, Senior Biotechnology Analyst at RBC Capital]

Thanks. Good morning, Joe and team. Congratulations on the progress, and thanks for taking my questions. Yeah. Great to see the setup for the long term, Joe. And of course, as there's always interest in the fourth quarter and nearer term, we certainly appreciate all the uncertainties and the drivers. But just on the pushes and pulls, could you just remind us of just a few items when it comes to the stocking of DefenCath facilities, the holding time, and the order frequency, just how to think about that? And maybe on another topic related, just when we think about the fourth quarter, how would we anticipate maybe some of the climate? The hurricanes, given you're certainly Southeast-based focus for sure with facilities, just any drivers on sort of the macro as it affects getting DefenCath to facilities and to patients? Thanks.

[Joe Todisco, CEO at CorMedix Inc]

Yeah. No, thanks, Greg. That was a good question. So for the initial customers that we have rolled out, we've been shipping direct to clinic. And to that extent, we're not seeing a lot of stocking. I think the estimates we're getting, maybe they're holding about 10 days on hand. As we onboard our LDO customer, we do think there'll be some stocking that they may hold 15 days to 30 days of inventory on hand. So it'll be a little bit more of a, call it a maybe a traditional turnover of inventory. For the fourth quarter, we did see a little bit of impact. Our initial customers and one of the new MDO customers that are deployed through the Southeast have a lot of clinics down there.

[Joe Todisco, CEO at CorMedix Inc]

So we saw a little bit of disruption over the first week of the month, but largely back, the trend we're seeing is largely back to what we had when we exited Q3. So we're focused now on onboarding new customers and trying to build that ramp as well.

[Gregory Renza, Senior Biotechnology Analyst at RBC Capital]

Great. That's helpful. And maybe just on the manufacturing and API, can you just remind us of what you're doing just to ensure you've got the sufficient quantities for future demand? Thanks again and congrats.

[Joe Todisco, CEO at CorMedix Inc]

Sure. Well, first, I'd say that we have more than sufficient finished dose inventory on hand today to take us through a decent part of next year. So from a finished dose inventory standpoint, I think we're in a really good position. We've also stockpiled a large amount of both of our key active ingredients, and we intend to purchase more in 2025 to kind of shore that up. We have two finished dosage manufacturers as well. We have ROVI in Spain, and we have Siegfried in Germany.

[Operator]

The next question comes from Brandon Folkes with Rodman & Renshaw. Please go ahead. Brandon, your line may be muted.

[Brandon Folkes, Former Managing Director of Equity Research at Rodman & Renshaw]

Hello? Can you hear me? Can you hear me?

[Joe Todisco, CEO at CorMedix Inc]

I can, Brandon. Yeah.

[Brandon Folkes, Former Managing Director of Equity Research at Rodman & Renshaw]

Okay. Let me start again. Apologies about that. Well, congrats on the quarter, first and foremost, and thanks for taking my questions. Just two questions from me. Firstly, just in terms of patient types at the different providers, have the mid-sized operators identified the patient types that were initially used in DefenCath? With how much consistency are you seeing across the providers in terms of where they're expecting to use DefenCath? And perhaps the other side of that, if you are seeing any variability, does that provide an opportunity to perhaps sort of cross-sell educate providers on where other providers are using DefenCath?

[Joe Todisco, CEO at CorMedix Inc]

Thanks, Brandon. So look, I think we've talked about this over the last couple of quarters, that some customers are triaging their patients based on the benefits verification. Others are looking at it on a high-risk basis kind of first. And I think that that's certainly how they're doing it in their respective institutions. So I don't know that there's consistency across all customers uniformly, but I think to your question about opportunity is that yes, it is absolutely an opportunity for growth, right, beyond whichever initial kind of triage criteria the customers have used. And we're certainly already in discussions with some of our customers that have identified patients that are high risk as to what is the next cohort and how much more broadly can we implement beyond high risk.

[Brandon Folkes, Former Managing Director of Equity Research at Rodman & Renshaw]

Great. Thanks, and then secondly for me, gross margin in the quarter looked extremely strong. How should we think about gross margin going forward, given this was your first full quarter of DefenCath in the market, and then especially as you bring on these sort of larger contracts, just even if it's just directionally, how do we think about gross margin from here?

[Joe Todisco, CEO at CorMedix Inc]

Look, I think gross margins are going to remain high. I mean, the initial gross margins you're seeing, a lot of that inventory was expensed as R&D, right? These batches were manufactured prior to some of them prior to getting approval. But that said, the cost of goods sold currently relative to the net selling price, it's a healthy gross margin that we'd expect through 2025.

[Brandon Folkes, Former Managing Director of Equity Research at Rodman & Renshaw]

Great. Thanks for taking my questions, and congrats on all the progress.

[Joe Todisco, CEO at CorMedix Inc]

Thank you.

[Operator]

The next question comes from Les Sulewski with Truist Securities. Please go ahead.

[Les Sulewski, VP of Spec Pharma at Truist Securities]

Good morning, guys. Thank you for taking my questions and congrats on the progress. Just to look at 3Q, any sort of metrics you can provide, whether it was a patient count or vial usage? And then second, out of the 60% access to dialysis centers that you've provided, do you have a sense of what percentage of that is utilized with DefenCath? And then how do you capture the rest of those patients within that pool? And then the second part to that question is, what is the strategy to capture the other 40% operators to get them on board? And how concentrated is that share? And I have a follow-up. Thank you.

[Joe Todisco, CEO at CorMedix Inc]

Okay. Thanks. So I mean, Les, in terms of third quarter metrics, I think we've put out currently what we're comfortable putting out. We can certainly revisit that as we move forward, whether we want to put out any patient numbers or potentially unit information. But right now, I think we're just comfortable putting out our sales data. So in terms of the 60% access, right, that is measured based on the total number of clinics where DefenCath could potentially be available, right, relative to the total number of clinics in the U.S. First, DefenCath is indicated for patients with CVCs, which are about 20% of dialysis patients overall. And what we're seeing varies by customers. Some customers, as I said, that are already implementing more broadly, it's probably a much higher percentage of their overall catheterized population.

[Joe Todisco, CEO at CorMedix Inc]

The initial LDO customer, which we've talked about in the past, looking to roll out with 4,000 patients, would be about 10% of their catheterized population. And certainly, we're working with them to grow beyond just that initial cohort. So there is a decent amount of, I think, upside opportunity potential as we move into 2025 across all customers. Now, you asked about the remaining 40%. Obviously, most of that is concentrated with one other LDO. We've been engaged with them over the past year and a half. They took a wait-and-see approach at the launch. We are in the process of re-engaging with them now, generating some additional data that we think that they'll find compelling. And hopefully, we can make some progress with them in the fourth quarter or into early next year. If not, I think we're very comfortable.

[Joe Todisco, CEO at CorMedix Inc]

We've got a really good trajectory with four of the top five dialysis providers in the U.S.

[Les Sulewski, VP of Spec Pharma at Truist Securities]

Got it. Very helpful. Second portion to this, I guess, is when can we expect some sort of meaningful contribution from the inpatient side? And then I believe you had an ND license agreement. That has been triggered, I believe, based on your 10-Q. What is the amount and when that will be paid out? Thank you.

[Joe Todisco, CEO at CorMedix Inc]

All right. Thanks. So I'll start with the inpatient, then I'll kick the ND Partners over to Matt. Look, so inpatient, if you look at the size of the opportunity right now, outpatient is about 90% of our volume opportunity. And certainly, it's got a much steeper ramp in terms of the ability to convert patients more quickly. So that's certainly what's driving and what's going to drive our material revenue, certainly in the short term. When we think about inpatient contribution, we look at it much more as a long-term potential revenue contributor. We see a lot of value in that segment, as we've talked about over the last two years. We see potentially better price durability there. But it's going to take a longer time to build share and penetration there, which is the nature of the inpatient market. So I have a long-term view there.

[Joe Todisco, CEO at CorMedix Inc]

I think we're very happy with the trajectory we've seen for sales on the outpatient side, and then we're going to continue to plug away on the inpatient side, building relationships and making progress. Matt, do you want to comment on ND Partners?

[Matt David, EVP and Chief Business Officer at CorMedix Inc]

Yeah, sure. No problem, Les. I'll just mention real briefly. Earlier this year, the company determined it was probable that the net sales milestones related to this would be achieved. And so as a result, we recorded a license intangible asset, which is included in accrued expenses in the consolidated balance sheet. The milestones were met during the three-month period ended September 30th, 2024. So this is something that you should probably see we would expect over the coming year to be paid.

[Les Sulewski, VP of Spec Pharma at Truist Securities]

Got it. Thank you, guys.

[Operator]

The next question comes from Serge Belanger with Needham & Company. Please go ahead.

[Serge Belanger, Managing Director of BioPharma Equity Research at Needham & Company]

Hi, good morning. And congrats on the quarter. A couple of questions around your anchor customer, US Renal Care. I guess the first one, just what percentage of 3Q sales did they represent? And then secondly, it sounds like it's been a solid partnership so far. They've had a successful DefenCath prioritization process. Just curious if this customer operates differently and whether you could replicate this partnership with some of the other partners that you've enlisted over this third quarter. Thanks.

[Joe Todisco, CEO at CorMedix Inc]

All right. Thanks, Serge. So yeah, and I think we put there might be some numbers in the queue around concentration of receivables, but yes. So US Renal Care accounted for an incredibly large percentage of third quarter sales, more than 90%. And I think in terms of trying to replicate how well a job they've done with implementation, yes, that's certainly something that we're trying to duplicate with other customers, particularly our LDO customers. So we're hopeful for that, and we're just going to keep executing over the next couple of months.

[Serge Belanger, Managing Director of BioPharma Equity Research at Needham & Company]

Maybe one follow-up. So Def is currently reimbursed at the WAC price. I think it's going to transition to ASP sometime in the early part of 2025. Just curious what that transition will look like and whether it could impact ordering patterns?

[Joe Todisco, CEO at CorMedix Inc]

I don't think it's expected to impact ordering patterns, Serge. This is something that's anticipated. And we've structured our agreements around the transition from WAC to ASP. And we don't expect ASP to erode that drastically initially, right? So yeah, this is somewhat of a known commodity. I think government will publish ASP at some point in late November or early December, I understand, for Q1. And I don't think it's going to be something that's problematic.

[Serge Belanger, Managing Director of BioPharma Equity Research at Needham & Company]

Thanks for taking my questions.

[Operator]

This concludes the audio portion of the Q&A session. I will now turn it over to Dan Ferry for written questions from the audience.

[Dan Ferry, Managing Director at LifeSci Advisors]

Thank you, Operator. So Joe, we have some written questions from the audience. The first one is, why isn't the company providing guidance? Do you have a sense when it may be possible to provide guidance for investors and analysts alike?

[Joe Todisco, CEO at CorMedix Inc]

Okay. Thanks, Dan. So look, I think I kind of touched on it in the script a little bit. We've got so much variability around the timing of onboarding our LDO customer. And think about a customer of that scale. And if they begin purchasing December 1st versus December 15th versus November 15th, there's a lot of variation there in what it could do for fourth quarter numbers. So we didn't feel comfortable putting out a range at this point in time. As we move through the quarter, we can certainly reevaluate that decision and see what we're once we have orders and see repetition, what we're comfortable putting out there. But right now, I think we're comfortable guiding that we do expect to be EBITDA positive, which is, I think, an incredible accomplishment in the first six to nine months of a product launch.

[Dan Ferry, Managing Director at LifeSci Advisors]

Excellent. All right. Thanks, Joe. Another one here. Could you expand a bit on TPN? What has the FDA feedback been to date, and what drove the company to make protocol amendments?

[Joe Todisco, CEO at CorMedix Inc]

Yeah, I'm going to turn that over to Liz in a moment, but we're excited about the TPN opportunity. We put our protocol into FDA. They provided some comments, I think, essentially around the statistics and the statistical calculations, but nothing really that's going to change our timelines or cost for the study, so Liz, you want to go ahead?

[Liz Hurlburt, Chief Clinical Strategy and Operations Officer at CorMedix Inc]

Sure. Thanks, Joe. So exactly. We received pretty minor feedback, wholly statistical in nature, on the TPN protocol. And we've absorbed that and integrated it into a new protocol amendment that is forthcoming. There's always really a fine line in protocol development, right? The need to address the critical unmet need of the patient population with a study that's designed to provide rigor and high clinical value, and one that can be translated post-approval and integrated into clinical practice in a meaningful way. So I think I'm confident now. We have a deeply experienced clinical regulatory and biostats team in place to meet those needs. And we'll be resubmitting that protocol amendment in the next couple of weeks.

[Dan Ferry, Managing Director at LifeSci Advisors]

Okay. Great. Thanks, both. Another one here, Joe. Can you share any feedback from the nephrology community regarding product use and practice since launch? And has there been anything in there that surprised you?

[Joe Todisco, CEO at CorMedix Inc]

I don't know if there's anything that I've found surprising. Obviously, I think some of the good things about utilizing DefenCath, right? There's no change to the workflow. I think the clinical results are really easy to understand. But I think overall, the feedback that we get is positive and continues to be overall positive. But Erin and Liz are in the field on a day-to-day basis. So I'm going to allow if they want to add some comments.

[Liz Hurlburt, Chief Clinical Strategy and Operations Officer at CorMedix Inc]

Yeah, I can add something there.

[Joe Todisco, CEO at CorMedix Inc]

Go ahead.

[Liz Hurlburt, Chief Clinical Strategy and Operations Officer at CorMedix Inc]

Yeah, thanks. Thanks, Joe. I think from an implementation standpoint, we've seen very positive feedback from nurses, physicians, and also patient advocates. On the inpatient side, the coordination and complexities involved are obviously complex and take time. But we have seen a crucial role being played by infectious disease in the infection prevention as well as quality community and guiding those processes across the inpatient setting. Liz, do you have anything else you want to add to that? No, I think you really covered it. I mean, I think we're just continually surprised to learn that despite all of these infection prevention efforts that are out there from a number of groups and a number of initiatives, that CRBSIs are continuing to happen. And there is still a great need to educate and raise awareness around them and prevention around them. So I think we've got a plan for that.

[Liz Hurlburt, Chief Clinical Strategy and Operations Officer at CorMedix Inc]

The team is actively addressing it, and I think we have really solid stewards in our clinician community and nursing communities that have adopted DefenCath and are really working with us to further that awareness within institutions too.

[Joe Todisco, CEO at CorMedix Inc]

Thanks, Liz.

[Dan Ferry, Managing Director at LifeSci Advisors]

Excellent. Yeah. Thanks, Liz. Thanks, Erin. Joe, one final one here. Can you give some thoughts on how CorMedix is thinking about financing going forward?

[Joe Todisco, CEO at CorMedix Inc]

Okay. Yeah, and I think we didn't touch on it in the script. We've talked about it in past earnings calls. Over the last quarter, with the higher volume and the appreciation in the stock, it made sense to use the ATM a little bit, and we did that, and we may continue to do that on a limited basis, but with the trajectory that we see for the business, obviously, I don't think we need to do any type of raise from an operational cash flow standpoint, right, to fund the business. The reasons why we may want to consider something in the future, we are getting a lot of inbound interest from large institutional investors, right? Long-only investors, the type of people that we may want in the stock that can't currently find liquidity on the market.

[Joe Todisco, CEO at CorMedix Inc]

And we also may want to start looking at building up a little bit of dry powder for business development. But we don't have anything, I'd say, imminently planned. But those would be the reasons why we might want to consider something down the road.

[Dan Ferry, Managing Director at LifeSci Advisors]

Okay. Great. Thanks, Joe. Operator, you may now close the call.

[Operator]

This concludes our question and answer session, and the conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Participants

Executives

• Joe Todisco, CEO
• Liz Hurlburt, Chief Clinical Strategy and Operations Officer
• Matt David, EVP and Chief Business Officer

Analysts

• Brandon Folkes, Former Managing Director of Equity Research at Rodman & Renshaw
• Gregory Renza, Senior Biotechnology Analyst at RBC Capital
• Jason Butler, Managing Director of Biotechnology Equity Research at JMP
• Dan Ferry, Managing Director at LifeSci Advisors
• Serge Belanger, Managing Director of BioPharma Equity Research at Needham & Company
• Les Sulewski, VP of Spec Pharma at Truist Securities