CorMedix Q3 2024 Earnings Call Transcript

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Provided by Quartr
October 30, 2024

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.
AI Generated. May Contain Errors.
Earnings Conference Call
CorMedix Q3 2024
00:00 / 00:00

There are 10 speakers on the call.

Operator

Good day, and welcome to the CorMedix Inc. 3rd Quarter 2024 Financial Results Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded.

Operator

I would now like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead.

Speaker 1

Thanks, operator. Good morning, and welcome to the CorMedix 3rd quarter 2024 earnings conference call. Leading the call today is Joe Tedisco, Chief Executive Officer of CorMedix. He is joined by Doctor. Matt David, Executive Vice President and CFO Beth Zelnick Kauffman, EVP and Chief Legal Officer Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer and Aaron Mistry, EVP and Chief Commercial Officer.

Speaker 1

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 facts 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 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.

Speaker 1

At this time, it is now my pleasure to turn the call over to Joe Taddisco, Chief Executive Officer of CorMedix. Joe, please go ahead.

Speaker 2

Thanks, Dan. Good morning, everyone, and thank you for joining the call. As we approach the end of our 1st calendar year of commercial launch of DefendCast, I'm incredibly proud of the team's efforts and pleased with the commercial results thus far. The Q3 marks the 1st full quarter of product shipments of Defend Cast as well as the Q1 of outpatient product utilization. Our net revenue for the Q3 of $11,500,000 exceeded Street consensus and was largely driven by our initial anchor customer U.

Speaker 2

S. Renal, which has done an exceptional job with the FEN CAT implementation within its clinics. We recently announced new agreements with 2 midsized dialysis operators and 1 large scale operator, which combined with our existing customers will provide patients access to FENcast and roughly 60% of dialysis clinics in the U. S. 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 Q4.

Speaker 2

While we have not issued revenue guidance for the Q4, based upon our current forecast, we do expect to be EBITDA positive for the Q4. With respect to guidance, there was a wide potential variability for 4th 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 midsized customers. Defend cats 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 Defend cats is appropriate and then implementing protocols based on those criteria. 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.

Speaker 2

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 Q4 revenue. For our new MDO customers, we expect orders to begin in November. With respect to our inpatient launch activities, we have made significant progress in terms of building defense champions within hospitals and health systems and scheduling P and T meetings with those institutions.

Speaker 2

A large number of P and T meetings occurred in the Q3 and we are in the process of fielding questions and providing additional information required for a formal decision. These P and T committee discussions required 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. We have started to see some utilization in the handful of hospitals that have completed P and T review early and added the FenCAT formulary and we are optimistic to build on that progress in 2025 as we continue our field efforts with the FenCAT advocates. Focusing now on our clinical developments, we announced in the Q2 that we received supportive feedback from FDA related to our proposed clinical pathway for adult total parenteral nutrition or TPM.

Speaker 2

Since then, we've 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 twenty twenty five. The company's goal for TPN is to obtain FDA approval for an expanded use of our turologine heparin catheterlux solution in the late 2027 to 2028 timeframe and we estimate annual peak sales potential in this indication to be in the range of $150,000,000 to $200,000,000 We will provide investors with updates on progress as we move forward. From a clinical budget standpoint, we anticipate the study to cost between $10,000,000 $12,000,000 with the majority of expense spanning the 2025 2026 calendar years. During our previous earnings call, we also announced 3 additional clinical initiatives, all expected to commence in the 2024 or early 2025 timeframe.

Speaker 2

Most meaningful of the 3 from a data value standpoint is our real world evidence study that we will run-in cooperation with our study partner, U. S. Renal Care. 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 $1,000,000 a year would be to generate real world evidence around the impact of the FenCath 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 ADAPA period to negotiate future sustainable reimbursement from Medicare Advantage Plans and other value based PR contracting entity.

Speaker 2

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. 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 $4,000,000 $6,000,000 spread over 5 years.

Speaker 2

Lastly, in addition to our other clinical initiatives, we plan to commence an expanded access program for high risk population, including but not limited to pediatric TPN, peritoneal dialysis patients with refractory peritonitis and neutropenic oncology patients utilizing a CBC. These high risk patients are those that have exhausted other infection prevention methods and unfortunately remain at significant risk for comorbidities and mortality. 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 TPM program.

Speaker 3

I would now like to

Speaker 2

turn the call over to Matt to discuss the company's Q3 financial results and financial position. Matt?

Speaker 4

Thanks, Joe, and good morning, everyone. I am pleased to be here today to provide an overview of our Q3 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. Results.

Speaker 4

With respect to our Q3 of 2024 financial results, our net revenue for the Q3 of 2024 amounted to $11,500,000 As Joe indicated, this marks the first full quarter since the BendCast became commercially available this past spring. Our net loss was approximately $2,800,000 or $0.05 per share compared with a loss of 9,700,000 dollars or $0.17 per share in the Q3 of 2023. The smaller net loss recognized in 2024 compared with 2023 was driven by the gross profits associated with the net sales of the Fencap. Operating expenses in the Q3 of 2024 increased approximately 33 percent to $14,100,000 compared with $10,500,000 in the Q3 of 2023. The increase was driven by higher selling and marketing and G and A expenses offset by a decrease in R and D.

Speaker 4

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 percent to $6,700,000 in the Q3 of 2024 compared with $4,100,000 in the Q3 of 2023. G and A expense increased 76 percent to $6,600,000 in the Q3 of 2024 versus $3,700,000 in the Q3 of 2023. 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 the FENCAP. The increase in G and A expense was primarily due to increases in personnel costs in preparation for activities related to the commercial launch as well as certain expenses previously expensed as a component of R and D prior to FDA approval.

Speaker 4

R and D expense decreased by approximately 73% to $700,000 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 and D efforts prior to the FDA approval of DefenCath have been recognized in selling and marketing or G and A expense. In addition, a portion of the costs related to the manufacturing of Defend Cat previously recognized in R and D are now capitalized as a result of the FDA approval. With respect to our 9 months year to date 2024 financial results, total net revenue during the 9 months year to date of 2024 amounted to $12,300,000 Total operating expenses during 9 months year to date of 2024 amounted to $45,500,000 compared with $33,300,000 in the 1st 9 months of 2023, an increase of 37%. R and D expense decreased 80% to $2,200,000 driven primarily by the approval of Defend Cat.

Speaker 4

Selling and marketing expense increased approximately 106 percent to $20,500,000 compared with the 1st 9 months of 2023 and G and A expense increased approximately 83 percent to 22,900,000 dollars compared with the comparable period in 2023. The increases in selling and marketing and G and A were driven primarily by new personnel and cost to support the commercial launch of the Fanc Cap. We recorded net cash used in operations during the 9 months year to date of 2024 of $45,000,000 compared with net cash used in operations of $27,700,000 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 $46,000,000 as of September 30, 2024.

Speaker 4

While we expect to begin to see cash collection from our accounts receivable in Q4, our cash position was supplemented in Q3 with approximately $12,400,000 in net proceeds from ATM issuance. We believe our cash, cash equivalents, short term investments and projected future operating cash flow gives the company the ability to fund operations for at least 12 months. 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 Q4. I will now turn the call back to Joe for closing remarks.

Speaker 5

Joe?

Speaker 2

Thanks, Matt. Chromitix is executing well on our launch of DefenCap 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 DefenCap beyond hemodialysis and beginning to scout for commercial stage business development opportunities to expand our product portfolio beyond DefenCap. I appreciate everyone's continued support CorMedix and I'm happy to take questions.

Operator

Our first question comes from Jason Butler with Simmons JMP. Please go ahead.

Speaker 4

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 it's 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?

Speaker 4

And then just lastly for me, can you speak to what you think about the trend for expenses operating expenses in 4Q? Thanks.

Speaker 2

Okay. All right. Thanks, Jason. Appreciate the question. 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.

Speaker 2

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 setting they're establishing criteria within their systems for whom defend CAT is appropriate and then they are implementing based on their criteria. And as I mentioned in the script, specifically with respect to our LDL customer, which we expect to follow a 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. We expect to see a similar type ramp to what we saw with our initial rollout with U.

Speaker 2

S. Renal. 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?

Speaker 2

Is that Exactly.

Speaker 4

Are you seeing that roughly similar balance between fee for service and the MedAdvantage?

Speaker 2

Yes. Well, look, claims data lags. So what we've seen with our initial customer rollout, I think, is patients or the facilities rather utilizing and 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.

Speaker 2

So we are seeing, I'd say, a broad dispersion of claims. I'd say overall though, in terms of you just look at the aggregate number of patients that are getting to FENCAS, it's I believe it's starting in the fee for service patients first and then expanding outlook. And your third question, Jason, I apologize, was it

Speaker 4

How should we think about expenses?

Speaker 2

Yes. Yes. Look, for the Q4, I think we've guided to the year that $15,000,000 to $18,000,000 by quarter. We've been

Speaker 5

on the low end of

Speaker 2

that range. We're below the range for this quarter. I think we'll be somewhere in the $15,000,000 to $17,000,000 range for the Q4 is what I would expect.

Speaker 4

Matt, is that Thanks for taking the question.

Speaker 2

I just want to verify that with Matt.

Speaker 4

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

Speaker 2

Yes, that's for Q1.

Operator

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

Speaker 6

Thanks. Good morning, Joe and team. Congratulations on the progress and thanks for taking my questions. Great to see the setup for the long term, Joe. And of course, as there's always interest in the Q4 and nearer term, we certainly appreciate all of the uncertainties and the drivers.

Speaker 6

But just on the pushes and pulls, could you just remind us of just a few items when it comes to the stocking of defense 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 Q4, how would we anticipate maybe some of the climate, the hurricanes or given you're certainly southeast based focus shore facilities. Just any drivers on sort of the macro as it affects getting defense gas to facilities and to patients? Thanks.

Speaker 2

Thanks, Greg. That's a good question. So for the initial customer 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.

Speaker 2

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 will be a little bit more of a call it maybe a traditional turnover of inventory. For the Q4, we did see a little bit of impact. Our initial customers and one of the new MDL customers that are deployed through the Southeast have a lot of clinics down there. So we saw a little bit of disruption over the 1st week of the month, but largely back the trend we're seeing is largely back to what we had when we exited Q3.

Speaker 2

So we're focused now on onboarding new customers and trying to build that ramp as well.

Speaker 6

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.

Speaker 2

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 doses 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 shore that up. We have 2 finished dosage manufacturers as well.

Speaker 2

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.

Speaker 7

Hello, can you hear me?

Speaker 2

I can, Brandon.

Speaker 7

Yes. Okay. Let me start again. Apologies about that. Congrats on the quarter, 1st and foremost, and thanks for taking my questions.

Speaker 7

Just two questions from me. Firstly, just in terms of patient types at the different providers, have the mid sized operators identify the patient types that were initially used in DefendCath. With how much consistency are you seeing across the providers in terms of where they're expecting to use DefendCath? 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 DefendCast?

Speaker 2

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.

Speaker 2

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.

Speaker 7

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 1st full quarter of DefendCare in the market and then especially with 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?

Speaker 2

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 expenses R and 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.

Speaker 7

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

Speaker 2

Thank you.

Operator

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

Speaker 3

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 the PEDF? And then how do you capture the rest of those patients within that pool?

Speaker 3

And then the second part to that question is, what is the strategy capture the other 40% operators to get them on board and how concentrated is that share? And I have a follow-up. Thank you.

Speaker 2

Okay, thanks. So I mean, lastly, in terms of Q3 metrics, I think we've put out currently what we're comfortable putting out. We can certainly revisit that as we move forward and 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 sale and data. So in terms of 60% access, right, that is measured based on the number the total number of clinics where defense cap could potentially be available, right, relative to the total number of clinics in the U.

Speaker 2

S. First, Defend Cat 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.

Speaker 2

The initial LDL 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 that's 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 that most of that is concentrated with one other LDO. We've been engaged with them over the past year and a half.

Speaker 2

They took a wait and see approach at the launch. We are in the process of reengaging 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 Q4 or into early next year. If not, I think we're very comfortable. We've got a really good trajectory with 4 of the top 5 dialysis providers in the U.

Speaker 2

S.

Speaker 3

Got it. Very helpful. Second portion to this, I guess, is when can we expect some sort of a meaningful contribution from the inpatient side? And then I believe you had a Endy license agreement. Is there that has been triggered, I believe, based on your 10 Q.

Speaker 3

What is the amount and when that will be paid out? Thank you.

Speaker 2

All right. Thanks. So I'll start with the inpatient, then I'll kick the Endy 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 deeper ramp in terms of the ability to convert patients more quickly.

Speaker 2

So that's certainly what's going to driving and what's going to drive our material revenue certainly

Speaker 4

in

Speaker 2

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 2 years. We see potentially better price durability there, but it's going to be it's going to take a longer time to build share and penetration there, just the nature of the inpatient market. So I have a long term view there.

Speaker 2

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 Endy Partners?

Speaker 4

Yes, sure. No problem, Les. I'll just mention real briefly. Earlier this year, the company determined that 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.

Speaker 4

The milestones were met during the 3 month period ended September 30, 2024. So this is something that you should probably see we would expect over the coming year to be paid.

Speaker 3

Got it. Thank you, guys.

Operator

The next question comes from Serge Belanger with Needham and Co. And Company. Please go ahead.

Speaker 5

Hi, good morning and congrats on the quarter. A couple of questions around your anchor customer U. S. Renal Care. I guess, the first one, just what percentage of 3Q sales that they represent?

Speaker 5

And then secondly, it sounds like it's been a solid partnership so far. They've had a successful death and cap prologistation 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 the Q3? Thanks.

Speaker 2

All right. Thanks, Serge. So yes, I think and I think we put there might be some numbers in the queue around concentration of receivables, but yes. So U. S.

Speaker 2

Renal accounted for an incredibly large percentage of 3rd 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 LVL customers. So we're hopeful for that and we're just going to keep executing over the next couple of months.

Speaker 5

Maybe one follow-up. TDAPA is currently reimbursed at the WACC 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?

Speaker 2

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 WACC to ASP and we don't expect ASP to erode that drastically initially. So, yes, 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.

Speaker 5

Thanks for taking my questions.

Operator

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

Speaker 1

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?

Speaker 2

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. Think about a customer of that scale and if they begin purchasing December 1 versus December 15 versus November 15, there's a lot of variation there in what it could do for 4th quarter numbers.

Speaker 2

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 1st 6 to 9 months of a product launch.

Speaker 1

Excellent. All right. Thanks, Joe. Another one here. Could you expand a bit on TPN?

Speaker 1

What is the FDA feedback been to date? And what drove the company to make protocol amendments?

Speaker 2

Yes. 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 fiscal calculations, but nothing really that's going to change our timelines or cost for the study.

Speaker 2

So Liz, you want to go ahead?

Speaker 8

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.

Speaker 8

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.

Speaker 7

Okay, great.

Speaker 1

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

Speaker 2

I don't know if there's anything that I've found surprising. Obviously, I think some of the good things about utilizing the SendCat, 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.

Speaker 2

But I'll Aaron and Liz are in the field on a day to day basis. So I mean, while if they want to add some comments.

Speaker 4

Yes.

Speaker 9

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 takes time, but we have seen a crucial role being played by infectious disease and 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?

Speaker 8

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's 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. The team is actively addressing it.

Speaker 8

And I think we have really solid stewards in our clinician community and nursing communities that have adopted Defend Cat and are really working with us to further that awareness within institutions too.

Speaker 2

Thanks, Liz.

Speaker 1

Excellent. Yes. Thanks, Liz. Thanks, Aaron. Joe, one final one here.

Speaker 1

Can you give some thoughts on how CorMedix is thinking about financing going forward?

Speaker 2

Okay. Yes, 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 appreciation in the stock, it made sense to use the APM a little bit and we did that and we may continue to do that in 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.

Speaker 2

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. We also may want to start looking at building up a little bit of dry powder for business development. 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.

Speaker 1

Okay, great. Thanks, Joe. Operator,

Speaker 4

you

Speaker 1

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

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