Q1 2025 CorMedix Inc Earnings Call

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

Speaker Change: Good morning, and welcome to the <unk> first quarter 2025 earnings Conference call.

Joseph: Leading the call today is Joseph <unk>, Chief Executive Officer of <unk>.

David: And by Dr. Matt, David Executive Vice President and CFO.

Speaker Change: Zelnick Hoffman, EVP, and chief legal and compliance officer, with Hurlbert, EVP, and Chief clinical strategy and operations Officer and Aaron Mystery.

David: And Chief commercial officer.

David: 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 1095.

David: These statements are statements other than statements of historical fact.

David: Regarding managements expectations beliefs goals.

David: And plans about the companys prospects and future financial position.

David: 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 <unk> filings with the SEC, which are available free of charge at the website or upon request from <unk>.

David: <unk> may not actually achieve the goals or plans described in these forward looking statements and investors should not place undue reliance on these statements.

David: <unk> does not intend to update these forward looking statements, except as required by law.

David: During this call the company will discuss certain non-GAAP measures of its performance.

David: GAAP to non-GAAP financial reconciliations and.

David: Supplemental financial information are provided in <unk> earnings release, and the current report on form 8-K filed with the SEC.

David: This information is available on the Investor Relations section of <unk> website.

David: At this time, it's now my pleasure to turn the call over to Joe to Disco Chief Executive Officer of <unk>. Joe. Please go ahead.

David: Yes.

Joe: Thanks, Dan.

Speaker Change: Good morning, everyone and thank you for joining us on this call.

Speaker Change: <unk> continues to have solid momentum with the launch of defend Kath highlighted by strong first quarter net sales of $39 1 million in line with our earlier pre announced results.

Speaker Change: <unk> EBITDA for the first quarter of $23 6 million was slightly above our earlier pre announced.

Speaker Change: We continue to see steady utilization growth with existing anchor customer U S renal care.

Speaker Change: IRC in Dci as well as new utilization with smaller outpatient dialysis operators and inpatient hospitals and health systems.

Speaker Change: For the month of April as an example, inpatient hospital ordering accounted for more than 6% of shipments up more than double from the first quarter.

Speaker Change: In early April we updated our net revenue guidance for <unk> sales to existing customers for the first half of the year and we guided to a range of 62 million to $70 million, which implied second quarter 2025, net revenue guidance of 23 million to $31 million based upon.

Speaker Change: First quarter results.

Speaker Change: I'm happy to say that based on order trends and inventory tracking we're able to further narrow our guidance towards the upper end of that range and currently project net revenue of approximately $770 million from existing purchasing customers over the first half of the year.

Speaker Change: As we stated on our previous call the moderate sequential decline in revenue anticipated between Q1 and Q2 of this year is largely due to the timing of shipments to U S renal care and which they purchased a few additional weeks of inventory in both the fourth quarter of 2024 and first quarter of 2025, respectively.

Speaker Change: We expect that beginning in the third quarter of this year for order volumes from U S renal care to normalize and we're closely track patient utilization.

Speaker Change: To that extent, we do anticipate utilization growth in the back half of 2025 as new patients initiate therapy at existing customers and as we add new customers in both the inpatient and outpatient settings.

Speaker Change: A large variable for a potential full year financial outlook is the timing and scale of uptake by our previously announced large dialysis operator customer.

Speaker Change: Over the last few weeks, we have seen increased levels of communication and planning related activities with medical and operations staff at the customer and to that extent, we are optimistic of achieving our target for a mid year 2025 implementation start.

Speaker Change: We intend to update investors once we have more definitive timeline from the customer.

Speaker Change: Turning back to the inpatient market our dedicated inpatient sales team is now fully staffed trained and operational in the field and we are hopeful to increase penetration as we move throughout 2025.

Speaker Change: Our partnership with WSI for promotion to federal facilities is also fully operational and we received and shipped our first orders to VA facilities in the first quarter.

Speaker Change: Focusing now on our clinical developments, we've begun our phase III clinical study for the reduction of Central line associated bloodstream infections, where collapses in adult patients receiving total parental nutrition or TPN through a central venous catheter.

Speaker Change: <unk> selection began in February and I'm happy to report that our first site is operational and actively screening patients and we expect our first patient to be dosed over the next few days.

Speaker Change: As a reminder, this is a 12 month study in less than a 150 patients and we are targeting completion of the study and submission of a new drug application to FDA by the end of 2026 or beginning of 2027.

Speaker Change: We recently submitted to FDA and application for orphan drug status for this indication and are awaiting fda's determination of eligibility.

Speaker Change: The company's goal for TPN is to obtain FDA approval for an expanded use of our to loading and heparin catheter lock solution in the late 2027 to early 2028 timeframe and.

Speaker Change: And we estimate annual peak sales potential in the syndication to be in the range of $150 million to $200 million.

Speaker Change: Based off of total addressable market size of $500 million to $750 million.

Speaker Change: We will provide investors with updates on progress in this important area of unmet need as we move forward.

Speaker Change: Our other clinical niches also continue to make solid progress.

Speaker Change: Excuse me a real world evidence study that is being run in cooperation with our study partner U S. Renal care has eclipsed 2000 patients and will hit its mid point in July.

Speaker Change: Our hope with this study and which we expect to evaluate patient outcomes over a 24 month period is to generate real world evidence around the impact of defend Kathy utilization on the cost of patient care infection rates hospitalizations mortality and multiple other metrics such as lost cheer time, and CRB assai related antibiotic use.

Operator: 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 1 on your telephone keypad. To withdraw your question, please press star then 2.

Summer.

Turning back to the inpatient market our dedicated impatient sales team is now fully staffed trained and operational in the field and we are hopeful to increase penetration as we move throughout 2025.

Our partnership with WSI for promotion to federal facilities is also fully operational and we received and shipped our first orders to VA facilities in the first quarter.

Speaker Change: Data from this study will be critical to our objective of making defend cap a standards of care catheter lock in the outpatient hemodialysis setting.

Operator: Please note, this event is being recorded.

Dan Ferry: I would now like to turn the conference over to Dan Ferry, Lifestyle Advisors. Please go ahead.

Speaker Change: In addition to our adult TPN and real World evidence studies, our study of <unk> in the pediatric hemodialysis population is on target to begin in the third quarter of this year and our expanded access program for high risk populations, including but not limited to pediatric TPN peritoneal dialysis patients with refractory repair Tonight.

Focusing now on our clinical developments.

Joseph Todisco: Good morning, and welcome to the CorMedix First Quarter 2025 Earnings Conference Call. Leading the call today is Joseph Todisco, Chief Executive Officer of CorMedix. He is joined by Dr. Matt David, Executive Vice President and CFO. That's Zelnick Kaufman, EVP and Chief Legal and Compliance Officer. Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer. And Erin Mistry, EVP and Chief Commercial Officer.

And we have begun our phase III clinical study for the reduction of central line associated bloodstream infections or collapses and adult patients receiving total parental nutrition or TPN through a central venous catheter.

Site selection began in February and I'm happy to report that our first site is operational and actively screening patients and we expect our first patient to be dosed over the next few days.

Speaker Change: And neutropenia oncology patients utilizing a CVC is now live.

Speaker Change: I would now like to turn the call over to Matt to discuss the company's first quarter financial results and financial position.

As a reminder, this is a 12 month study in less than 150 patients and we are targeting completion of the study and submission of a new drug application to FDA by the end of 2026 or beginning of 2027.

Joseph Todisco: 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 meeting 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 positions. 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.

Speaker Change: Thanks, Joe and good morning, everyone I am pleased to be here today to provide an overview of our first quarter 2025 financial results as well as an update on <unk> cash position.

We recently submitted to FDA and application for orphan drug status for this indication and are awaiting fda's determination of eligibility.

Speaker Change: The company has filed its quarterly report on Form 10-Q for the quarter ended March 31, 2025, I urge you to read the information contained in the report for a more complete discussion of our financial results.

The company's goal for TPN is to obtain FDA approval for an expanded use of our <unk> and heparin catheter lock solution in the late 2027 to early 2028 timeframe and.

Speaker Change: With respect to our first quarter of 2025 financial results.

Speaker Change: Our net revenue for the first quarter of 2025 amounted to $39 1 million.

And we estimate annual peak sales potential in the syndication to be in the range of $150 million to $200 million.

Speaker Change: <unk> achieved profitability for the first quarter as our net income was $20 6 million or <unk> 32 per share compared with a net loss of $14 5 million or <unk> 25 per share in the first quarter of 2024.

Based off of total addressable market size of $500 million to $750 million.

Joseph Todisco: 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.

We will provide investors with updates on progress in this important area of unmet need as we move forward.

Joseph Todisco: CorMedix does not intend to update these forward-looking statements except as required by law.

Our other clinical niches also continue to make solid progress.

Speaker Change: The net income recognized in 2025 was driven by the gross profit associated with the net sales of defend cap.

Matthew David: During this call, the company will discuss certain non-GAAP measures of its performance. GAAP to non-GAAP financial reconciliations and supplemental financial information are provided in CorMedix earnings release and the current report on Form 8K filed with the SEC. This information is available on the investor relations section of CorMedix's website.

[noise] excuse me a real world evidence study that is being run in cooperation with our study partner U S. Renal care has eclipsed 2000 patients and will hit its mid point in July.

Speaker Change: Operating expenses in the first quarter of 2025 increased approximately 9% to $17 4 million compared with $15 9 million in the first quarter of 2024.

Our hope with this study and which we expect to evaluate patient outcomes over a 24 month period is to generate real world evidence around the impact of defend Kathy utilization on the cost of patient care infection rates hospitalizations mortality and multiple other metrics such as loss cheer time, and CRB assai related antibiotic use.

Speaker Change: R&D expense increased by approximately 281% to $3 2 million from approximately 800000 in the first quarter of 2024, driven by the increase in personnel and clinical trial services in support of our ongoing clinical programs.

Joseph Todisco: 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. Thanks, Dan. Good morning, everyone. And thank you for joining us on this call. CorMedix continues to have solid momentum with the launch of Defendcast, highlighted by strong first quarter net sales of $39.1 million, in line with our earlier pre-announced results. adjusted EBITDA for the first quarter of $23.6 million was slightly above our earlier pre-announcement. We continue to see steady utilization growth with existing anchor customer U.S. Renal Care, IRC and DCI, as well as new utilization with smaller outpatient dialysis operators and inpatient hospitals and health systems. For the month of April, as an example, inpatient hospital ordering accounted for more than 6% of shipments, up more than double from the first quarter.

Data from this study will be critical to our objective of making defend caf standards of care catheter lock in the outpatient hemodialysis setting.

Speaker Change: Selling and marketing expense decreased 29% to $4 5 million in the first quarter of 2025, compared with $6 3 million in the first quarter of 2024.

In addition to our adult TPN and real World evidence studies, our study of defend Kathryn the pediatric hemodialysis population is on target to begin in the third quarter of this year.

Speaker Change: G&A expense increased 11% to $9 7 million in the first quarter of 2025 versus $8 7 million in the first quarter of 2024.

And our expanded access program for high risk populations, including but not limited to pediatric TPN peritoneal dialysis patients with refractory peritonitis and neutropenia oncology patients utilizing a CVC is now live.

Speaker Change: The decrease in selling and marketing expense is consider temporary and related to the timing of our prior internal salesforce versus the ramping of costs related to our outsource sales force, we expect those costs to be normalized for the second quarter.

I would now like to turn the call over to Matt to discuss the company's first quarter financial results and financial position Matt.

Speaker Change: The increase in G&A expense was primarily driven by noncash charges for stock based compensation.

Matt: Thanks, Joe and good morning, everyone.

Speaker Change: We recorded net cash provided by operations during the first quarter of 2025 of $19 7 million compared with net cash used in operations of $17 3 million in the first quarter of 2024.

Joseph Todisco: In early April, we updated our Net Revenue Guidance for Defendcast sales to existing customers for the first half of the year, and we guided to a range of $62 million to $70 million. which implied second quarter 2025 net revenue guidance of $23 million to $31 million based upon first quarter results. I'm happy to say that based on order trends and inventory tracking, we're able to further narrow our guidance toward the upper end of that range and currently project net revenue of approximately $70 million from existing purchasing customers over the first half of the year. As we stated on our previous call, the moderate sequential decline in revenue anticipated between Q1 and Q2 of this year is largely due to the timing of shipments to U.S.

Matt: Im pleased to be here today to provide an overview of our first quarter 2025 financial results as well as an update on <unk> cash position.

Matt: The company has filed its quarterly report on Form 10-Q for the quarter ended March 31, 2025, I urge you to read the information contained in the report for a more complete discussion of our financial results.

Speaker Change: The increase was driven by our net income for the period versus a net loss in the comparison period.

Speaker Change: The company has cash and cash equivalents of $77 5 million as of March 31, 2025.

Matt: With respect to our first quarter of 2025 financial results.

Matt: Our net revenue for the first quarter of 2025 amounted to $39 1 million.

Speaker Change: As described previously we are guiding to 2000 22025 cash operating expenses of approximately $72 million to $78 million. The increase over 2024 spending levels is expected to be largely driven by an increase in R&D spending on our clinical initiatives I will now turn the call back over to Joe for closing remarks.

Matt: <unk> achieved profitability for the first quarter as our net income was $20 6 million or <unk> 32 per share compared with a net loss of $14 5 million or 25 per share in the first quarter of 2024.

Joe: Joe Thanks, Matt.

Matt: The net income recognized in 2025 was driven by the gross profit associated with the net sales of defend cap.

Joseph Todisco: Renal Care, in which they purchased a few additional weeks of inventory in both the fourth quarter of 2024 and first quarter of 2025, respectively. We expect that beginning in the third quarter of this year for order volumes from U.S. Renal Care to normalize and more closely track patient utilization. To that extent, we do anticipate utilization growth in the back half of 2025 as new patients initiate therapy at existing customers and as we add new customers in both the inpatient and outpatient settings. A large variable for our potential full-year financial outlook is the timing and scale of uptake by our previously announced large dialysis operator customer.

Speaker Change: <unk> is working diligently on all fronts to increase our existing customer base as well as expanding defend cast to new therapeutic indications.

Matt: Operating expenses in the first quarter of 2025 increased approximately 9% to $17 4 million compared with $15 9 million in the first quarter of 2024.

Joe: Appreciate everyone's continued support in <unk> and I'm happy to take questions.

Joe: Okay.

Joe: We will now begin the question and answer session.

Joe: To ask a question you May press Star then one on your telephone keypad.

Matt: R&D expense increased by approximately 281% to $3 2 million from approximately 800000 in the first quarter of 2024, driven by the increase in personnel and clinical trial services in support of our ongoing clinical programs.

Joe: If youre using a speakerphone please pick up your handset before pressing the keys.

Joe: If at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.

Joe: At this time, we will pause momentarily to assemble our roster.

Matt: Selling and marketing expense decreased 29% to $4 5 million in the first quarter of 2025, compared with $6 3 million in the first quarter of 2024.

Gregory: Our first question comes from Gregory <unk> from RBC capital. Please go ahead.

Joseph Todisco: Over the last few weeks, we have seen increased levels of communication and planning-related activities with medical and operations staff at the customer, and to that extent, we are optimistic of achieving our target for a mid-year 2025 implementation start.

Matt: G&A expense increased 11% to $9 7 million in the first quarter of 2025 versus $8 7 million in the first quarter of 2024.

Speaker Change: Great. Thanks, Good morning, Joe and Matt Congrats on the progress and thanks for taking my questions.

Speaker Change: Joe maybe just starting with the LBO partnership it sounds like at the top you mentioned just some degree of optimism and the progress just curious if you could just provide how that has how your perceptions and your engagement. There has evolved since we last spoken in the last in the last quarter.

Matt: The decrease in selling and marketing expense is consider temporary and related to the timing of our prior internal salesforce versus the ramping of costs related to our outsource sales force, we expect those costs to be normalized for the second quarter.

Joseph Todisco: We intend to update investors once we have a more definitive timeline from the customer. Turning back to the inpatient market, our dedicated inpatient sales team is now fully staffed, trained, and operational in the field, and we are hopeful to increase penetration as we move throughout 2025. Our partnership with WSI for promotion to federal facilities is also fully operational, and we received and shipped our first orders to VA facilities in the first quarter.

Speaker Change: Or so and what do you think.

Matt: The increase in G&A expense was primarily driven by noncash charges for stock based compensation.

Speaker Change: <unk> wants to see just operationally and with respect to outcomes.

Matt: We recorded net cash provided by operations during the first quarter of 2025 of $19 7 million compared with net cash used in operations of $17 3 million in the first quarter of 2020 for the.

Speaker Change: Perhaps opening up to that to that broader population, how that's longer term, but just wanted to see how youre driving to support those goals.

Speaker Change: Thanks, Greg.

Speaker Change: And with regard to the size of the population I am not going to I'm not going to speak for four on behalf of the LDL. They haven't given us any updated guidance in terms of number of patients right. We're still working off of prior feedback and that's what we're prepared for.

Joseph Todisco: Focusing now on our clinical developments, we've begun our phase three clinical study for the reduction of central line-associated bloodstream infections, or CLABSIs, in adult patients receiving total parental nutrition, or TPN, through a central venous catheter. Site selection began in February, and I'm happy to report that our first site is operational and actively screening patients, and we expect our first patient to be dosed over the next few days. As a reminder, this is a 12-month study in less than 150 patients, and we are targeting completion of the study and submission of a new drug application to FDA by the end of 2026 or beginning of 2027.

Matt: The increase was driven by our net income for the period versus a net loss in the comparison period.

Matt: The company has cash and cash equivalents of $77 5 million as of March 31, 2025. As described previously we are guiding to 2000 22025 cash operating expenses of approximately $72 million to $78 million. The increase over 2024 spending levels is expected to be largely driven.

Speaker Change: But also have the ability to scale up.

Speaker Change: Quite quickly should we need to.

Speaker Change: As I said in the script over the last few weeks, we've seen heightened levels of kind of preparatory activity the types of things that would need to be done.

Speaker Change: And by an increase in R&D spending on our clinical initiatives I will now turn the call back over to Joe for closing remarks, Joe Thanks, Matt.

Speaker Change: Right to initiate utilization certainly nothing is ever set in stone right with customers and.

Speaker Change: We are waiting for an implementation date, but as I said, we're optimistic or cautiously optimistic as you want to take it.

Speaker Change: <unk> is working diligently on all fronts to increase our existing customer base as well as expanding defend cast to new therapeutic indications.

Joseph Todisco: We recently submitted to FDA an application for orphan drug status for this indication and are awaiting FDA's determination of eligibility. The company's goal for TPN is to obtain FDA approval for an expanded use of our tyrolidine and heparin catheter lock solution in the late 2027 to early 2028 time frame. And we estimate annual peak sales potential in this indication to be in the range of $150 million to $200 million. based off a total addressable market size of $500 million to $750 million.

Speaker Change: And we're ready to go as soon as they hopefully pull the trigger.

Speaker Change: I appreciate everyone's continued support in <unk> and I'm happy to take questions.

Speaker Change: On a per order.

Speaker Change: Okay.

Speaker Change: Got it and just maybe just on inventory inventory control. Obviously this is a key priority for operators and you've commented on some some of that lumpiness.

Speaker Change: We will now begin the question and answer session.

Speaker Change: To ask a question you May press Star then one on your telephone keypad.

Speaker Change: If youre using a speakerphone please pick up your handset before pressing the keys.

Speaker Change: Maybe just some comments Joe on.

Speaker Change: The policy and macro volatility that in many sectors are experiencing how are you.

Speaker Change: If at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.

Speaker Change: How are you reacting to that.

Speaker Change: At this time, we will pause momentarily to assemble our roster.

Speaker Change: Is there anything that you think is.

Joseph Todisco: We will provide investors with updates on progress in this important area of unmet need as we move forward. Our other clinical initiatives also continue to make solid progress. Our real-world evidence study that is being run in cooperation with our study partner, U.S. Renal Care, has eclipsed 2,000 patients and will hit its midpoint in July. Our hope with this study, in which we expect to evaluate patient outcomes over a 24-month period, is to generate real-world evidence around the impact of defend cath utilization on the cost of patient care, infection rates, hospitalizations, mortality, and multiple other metrics such as lost chair time and CRBSI-related antibiotic use.

Speaker Change: Predictable or it could be that could affect some of the usual kind of lumpiness. When it comes to when it comes to selling into it and that providing defend cat.

Gregory <unk>: Our first question comes from Gregory <unk> from RBC capital. Please go ahead.

Speaker Change: <unk>.

Gregory <unk>: Great. Thanks, Good morning, Joe and Matt Congrats on the progress and thanks for taking my questions.

Craig: Yes, no. Thanks Craig.

Craig: At the macro level issues right now that are kind of going on call. It <unk>.

Gregory <unk>: Joe maybe just starting with the LBO partnership it sounds like at the top you mentioned just some degree of optimism and the progress just curious if you could just provide how that has how your perceptions and your engagement. There has evolved since we last spoken in the last in the last quarter.

Craig: Worldwide, whether it's tariff related or other kind of supply chain change. Your strengths are arent really an issue for US right. Our lumpiness was entirely rate largely caused by just a price incentive that a customer had to kind of move some inventory.

Gregory <unk>: Or so what do you think.

Craig: Or take a little bit of an inventory earlier and they are working through that inventory now which is why we.

Gregory <unk>: <unk> wants to see just operationally and with respect to two outcomes before perhaps opening up to that to that broader population, how that's longer term, but just wanted to see how youre driving to support those goals.

Craig: Encouraging investors to look at the first half of the year kind of as a lump sum period.

Joseph Todisco: Data from this study will be critical to our objective of making DefendCat the standard of care catheter to the lock in the outpatient hemodialysis setting.

Craig: From an inventory prep standpoint, we've got a significant amount of active pharmaceutical ingredient on hand for both heparin and <unk>.

Craig: No. Thanks, Craig.

Joseph Todisco: In addition to our adult TPN and real-world evidence studies, our study of DefendCath and the pediatric hemodialysis population is on target to begin in the third quarter of this year. And our 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 CBC, is now live.

Craig: And with regard to the size of the population I am not going to I'm not going to speak for on behalf of the LDL. They haven't given us any updated guidance in terms of number of patients right. We're still working off of prior feedback and that's what we're prepared for but also have the ability to scale up.

Craig: That should work.

Craig: He will cover not only our current demand run rate for for more than a year, but also a good good amount of scale up should we need to.

Craig: To support.

Craig: Any increased customer demand we.

Craig: Quite quickly should we need to.

Craig: We've also got.

Craig: Good runway of finished dosage inventory manufactured we have two finished dosage manufacturers that have been.

Craig: As I said in the script over the last few weeks, we've seen heightened levels of kind of preparatory activity the types of things that would need to be done.

Matthew David: I would now like to turn the call over to Matt to discuss the company's first quarter financial results and financial position. Matt. Thanks, Joe. Good morning, everyone. I am pleased to be here today to provide an overview of our first quarter 2025 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 March 31st, 2025. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our first quarter of 2025 financial results, our net revenue for the first quarter of 2025 amounted to $39.1 million.

Craig: Quantified by the FDA. So we so we have some flexibility there. So so overall inventory is really not a constraint for us or something that I would foresee, causing any any fluctuations in our in our.

Craig: Right two to initiate utilization certainly nothing is ever set in stone right with customers and.

Craig: We're waiting for implementation date, but as I said, we're optimistic or cautiously optimistic as you want to take it.

Craig: And our earnings.

Craig: Yes.

Craig: Got it that makes sense, congrats again I'll hop back into the queue.

Greg: Thanks, Greg.

Craig: And we're ready to go as soon as they hopefully pull the trigger.

Craig: Thank you.

Speaker Change: The next question comes from Ryan <unk> from Leerink Partners. Please go ahead.

Craig: On a per order.

Craig: Got it and just maybe just on inventory inventory control. Obviously this is a key priority for operators and you've commented on some some of that lumpiness.

Speaker Change: Hey, good morning, everyone.

Speaker Change: A couple from me first one could you talk a bit more about the main drivers behind the one key revenue number, especially given the successful implementation I was curious does some of that strength come from U S renal or some of the small and medium dialysis centers and what metrics are giving you more confidence to point to the top end of your.

Joe: Maybe just some comments Joe on.

Joe: The policy and macro volatility of that now many sectors.

Matthew David: CorMedix achieved profitability for the first quarter as our net income was $20.6 million or $0.32 per share compared with a net loss of $14.5 million or $0.25 per share in the first quarter of 2024. The net income recognized in 2025 was driven by the gross profits associated with the net sales of the FENCAP. Operating expenses in the first quarter of 2025 increased approximately 9% to $17.4 million compared with $15.9 million in the first quarter of 2024. R&D expense increased by approximately 281% to $3.2 million from approximately $800,000 in the first quarter of 2024, driven by the increase in personnel and clinical trial services in support of our ongoing clinical programs. Selling and marketing expense decreased 29% to $4.5 million in the first quarter of 2025 compared with $6.3 million in the first quarter of 2024.

Joe: And saying you know how are you.

Joe: How are you reacting to that.

Joe: There anything that you think is.

Joe: Predictable or it could be that could affect some of the usual kind of lumpiness. When it comes to U M. When it comes to selling into it and providing defend cats to the operators.

Speaker Change: Your first half guidance.

Rhonda: Thanks Rhonda.

Speaker Change: <unk>.

Speaker Change: Look I think we have a number in the Q exactly what percentage.

Greg: Yes, no. Thanks, Greg.

Speaker Change: <unk>.

Speaker Change: Our customers.

Greg: On the macro level issues right now that are kind of going on call. It <unk>.

Speaker Change: Our top customer accounts for.

Greg: Worldwide, whether it's tariff related or other kind of supply chain change. Your strengths are arent really an issue for US right. Our lumpiness was entirely rate are largely caused by just a price incentive that a customer had to kind of move some inventory.

Speaker Change: I do believe that U S. Renal first quarter was still more than 80% of of.

Speaker Change: Shipments. So obviously it is a large driver there are there currently are our biggest anchor customer.

Speaker Change: But we did see good growth in the first quarter as I said with smaller customers with hospitals.

Speaker Change: On the inpatient side I think first quarter overall was around 3% of shipments, but a little bit larger percentage of dollars, but theres, a little bit better pricing.

Greg: Or take a little bit of an inventory earlier and they are working through that inventory now which is why we.

Greg: Encouraged investors to look at the first half of the year kind of as a lump sum period.

Speaker Change: In the hospital inpatient segment at this point of time.

Greg: From an inventory prep standpoint, we've got a significant amount of active pharmaceutical ingredient on hand for both heparin and <unk>.

Speaker Change: We talk about <unk>.

Speaker Change: Guidance and kind of are in our thoughts around it being at the top end of the range.

Matthew David: GNA expense increased 11% to $9.7 million in the first quarter of 2025 versus $8.7 million in the first quarter of 2024. The decrease in selling and marketing expense is considered temporary and related to the timing of our prior internal sales force versus the ramping of costs related to our outsourced sales force. We expect those costs to be normalized for the second quarter. The increase in G&A expense was primarily driven by non-cash charges for stock-based compensation. We recorded net cash provided by operations during the first quarter of 2025 of $19.7 million, compared with net cash used in operations of $17.3 million in the first quarter of 2024.

Speaker Change: We're doing a pretty good analysis now on inventory certainly at U S renal care, but a couple of your other customers have begun sharing inventory reports we have.

Greg: That should work.

Greg: We'll cover not only our current demand run rate for for more than a year, but also a good good amount of scale up should we need to to.

Speaker Change: A little bit of visibility now into what their weekly dispensing utilization is so.

Greg: To support.

Greg: Any increased customer demand.

Greg: We've also got.

Speaker Change: We're basically making a projection right of what they have on hand, what the rundown is going to be and what we think new orders are going to be over the next couple of cut.

Greg: Good runway of finished dosage inventory manufactured we have two finished dosage manufacturers that have been.

Greg: Qualified by the FDA. So we have some flexibility there. So so overall inventory is really not a constraint for us or something that I would foresee, causing any any fluctuations in our in our.

Speaker Change: A couple of weeks.

Yeah.

Speaker Change: Okay got it and one last follow up for me I was also curious thinking about the outstanding LDL any updates there on what youre thinking about or what they might want to see to Kim are comfortable or just implement more are using different cas and enter a contract et cetera.

Greg: And our earnings.

Greg: Got it that makes sense, congrats again I'll hop back into the queue.

Greg: Thanks, Greg.

Greg: Thank you.

Matthew David: The increase is driven by our net income for the period versus the net loss in the comparison period. The company has cash and cash equivalents of $77.5 million as of March 31st, 2025. As described previously, we are guiding to 2025 cash operating expenses of approximately $72 to $78 million. The increase over 2024 spending levels is expected to be largely driven by an increase in R&D spending on our clinical initiatives.

Speaker Change: Question comes from Brian <unk> from Leerink Partners. Please go ahead.

Speaker Change: Yep.

Speaker Change: As I said to Greg I'm, not going to speak for them in terms of what they might or might not be looking at in terms of implementation or timing.

Speaker Change: Hey, good morning, everyone.

Speaker Change: A couple from me first one could you talk a bit more about the main drivers behind the one key revenue number, especially given the successful implementation I'm. Just curious does some of that strength come from U S renal or some of the small and medium dialysis centers and what metrics are giving you more confidence to point to the top end of your.

Speaker Change: I can only speak to the questions that were being asked and what we're being asked to provide.

Speaker Change: Essentially our all of the same things that we've provided to other customers right as we as we've ramped up.

Speaker Change: Toward implementation so.

Speaker Change: As I get more information I'm certainly going to.

Speaker Change: Update update investors, but right now as I said I'm comfortable and we are optimistic that.

Speaker Change: Your first half guidance.

Joseph Todisco: I will now turn the call back over to Joe for closing remarks. Joe? Thanks, Matt. CorMedix is working diligently on all fronts to increase our existing customer base, as well as expand the use of Defendcast to new therapeutic indications.

Rhonda: Thanks Rhonda.

Speaker Change:

Speaker Change: We are on the timelines that we've communicated previously.

Speaker Change: <unk>.

Speaker Change: Look I think we have a number in the Q exactly what percentage.

Speaker Change: Okay got it thank you.

Speaker Change: <unk>.

Speaker Change: Our customers.

Joseph Todisco: I appreciate everyone's continued support in CorMedix, and I'm happy to take questions. We will now begin the question and answer session. To ask a question, you may press star then 1 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.

Speaker Change: Thank you.

Speaker Change: Our top customer accounts for.

Les Sulewski: Your next question comes from Les Sulewski from tourists Securities. Please go ahead.

Speaker Change: I do believe that U S. Renal first quarter was still more than 80% of of shipments. So obviously it is a large driver. There are there currently are our biggest anchor customer.

Les Sulewski: Good morning, Thank you for taking my questions and congrats on the progress guys.

Speaker Change: But we did see good growth in the first quarter as I said with smaller customers with hospitals.

Speaker Change: So Joe perhaps maybe you can talk about U S renal.

Les Sulewski: Start there.

Speaker Change: On the inpatient side I think first quarter overall was around 3% of shipments, but a little bit larger percentage of dollars spread is a little bit better pricing.

Les Sulewski: Do you expect the order rates to normalize I guess, maybe can you provide us a sense of what patient pool or a percent of their patient pool.

Operator: At this time, we will pause momentarily to assemble our roster.

Les Sulewski: Is on defense calf or there are additional cohorts that can be offered to implement that and then in regards to other customers have they notified you on when they start they will start taking in shipments.

Speaker Change: In the hospital in patient segment at this point of time.

Speaker Change: When we talk about guidance and kind of are in our thoughts around it being at the top end of the range.

Gregory Renza: Our first question comes from Gregory Renza from RBC Capital, please go ahead. Great, thanks. Good morning, Joe and Matt. Congrats on the progress and thanks for taking my questions. Joe, maybe just starting with the LDO partnership, it sounds like at the top you mentioned just some degree of optimism in the progress. Just curious if you could just provide how that has, how your perceptions and your engagement there has evolved since we've last spoken in the last quarter or so. And what do you think the LDO wants to see just operationally and with respect to outcomes before perhaps opening up to that broader population?

Speaker Change: So we're doing a pretty good analysis now on an inventory certainly at U S renal care, but a couple of years our customers have begun sharing inventory reports we have.

Les Sulewski: And then just kind of your ability to foresee the utilization tracking I know, you're just kind of shed some insights into customers, providing some of that but.

Les Sulewski: Are you able to kind of differentiate what utilization versus the inventory buildup and then I have a follow up as well and reimbursement.

Speaker Change: A little bit of visibility now into what their weekly dispensing utilization is so.

Speaker Change: Alright, Thanks last one and I'll try and triangle.

Speaker Change: We're basically making a projection right of what they have on hand, what the rundown is going to be and what we think new orders are going to be over the next couple of a couple.

Les Sulewski: <unk>.

Les Sulewski: So when we talk about U S renal care and kind of order rates normalizing.

Les Sulewski:

Speaker Change: A couple of weeks.

Les Sulewski: And I think I think you're what you're really asking is kind of what's the what's the runway for growth over over the back part of the year I think there's some runway for growth I think we're probably more a little bit more than 80%.

Speaker Change: Okay got it and one last follow up for me I was also curious thinking about the outstanding LDL any updates there on what youre thinking about or what they might want to see to camera comfortable or just implement more using different casts and enter a contract et cetera.

Joseph Todisco: I know that's longer term, but I just want to see how you're driving to support those goals.

Les Sulewski: Implemented right within the kind of the eligible patient population based on the criteria. They set up but I do think there's still opportunity and there's always new patients that come in and begin that dialysis that meet the criteria. So.

Joseph Todisco: Now, thanks, Greg. And, you know, with regard to the size of the population, I'm not going to speak for, you know, on behalf of the LDO. They haven't given us any updated guidance in terms of number of patients, right? We're still working off of prior feedback, and that's what we're prepared for, but also have the ability to scale up, you know, quite quickly, you know, should we need to. You know, as I said in the script, over the last few weeks, we've seen, you know, heightened levels of kind of preparatory activity, you know, the types of things that would need to be done, right, to initiate utilization.

Speaker Change: Yep.

Speaker Change: As I said to Greg I'm, not going to speak for them in terms of what they might or might not be looking at in terms of implementation or timing.

Les Sulewski:

Les Sulewski: I'd say with the other mid sized customers is a little bit more more runway I would say for growth. We've obviously implemented.

Speaker Change: I can only speak to the questions that were being asked and what we're being asked to provide.

Speaker Change: Essentially our all of the same things that we've provided to other customers right as we as we've ramped up.

Les Sulewski: More recently right. So we're still kind of in the ramping phase I think.

Les Sulewski: With both IRC in Dci as well as with.

Speaker Change: Toward implementation so.

Les Sulewski: A number of a number of the smaller customers on utilization tracking I would say.

Speaker Change: As I get more information I'm certainly going to.

Speaker Change: Update update investors, but right now as I said I'm comfortable we're optimistic that.

Joseph Todisco: Certainly, you know, nothing is ever set in stone, right, with customers, and, you know, we're waiting for an implementation date, but as I said, you know, we're optimistic or cautiously optimistic, as you want to take it, and, you know, we're ready to go as soon as they, you know, hopefully pull the trigger on a purchase order. Got it.

Les Sulewski: At least with U S renal care, which I will correct. The number I gave before I think for this quarter was 78% of.

Speaker Change: We're on the timeline set that we've communicated previously.

Les Sulewski: Shipments in the first quarter or of revenue in the first quarter.

Speaker Change: Okay got it thank you.

Les Sulewski: We do have pretty good visibility as to what is <unk>.

Speaker Change: Thank you.

Les Sulewski: Utilization versus what is what is inventory and thats.

Speaker Change: Your next question comes from Les Sulewski from tourists Securities. Please go ahead.

Les Sulewski: The basis for which we've we've amended our guidance and now we're guiding towards the upper end of our range.

Joseph Todisco: And maybe just on inventory control, obviously, this is a key priority for operators, and you've commented on some of that lumpiness. Maybe just some comments, Joe, on kind of the policy and macro volatility that many sectors are experiencing. How are you reacting to that? Is there anything that you think is unpredictable or could be that could affect some of the usual kind of lumpiness when it comes to when it comes to selling into it and providing DefendCast to them?

Les Sulewski: Good morning, Thank you for taking my questions and congrats on the progress guys.

Les Sulewski: Got it very helpful on the reimbursement front, so now maybe kind of looking ahead.

Les Sulewski: Maybe you can talk about U S renal start there.

Les Sulewski: Medicare advantage being a bigger share.

Les Sulewski: You expect the order rates to normalize I guess, maybe can you provide us a sense of what patient pool.

Les Sulewski: Can we kind of I guess assume theres a potential for a reimbursement negotiation with Medicare advantage and the early phases of the TDAP a period or is this more of a kind of a concrete decision that will coincide with.

Les Sulewski: One of their patient pool.

Les Sulewski: Is defend caf or there are additional cohorts that can be offered to implement that and then in regards to other customers have they notified you on when they start they will start taking in shipments.

Les Sulewski: And of TDAP a coverage.

Les Sulewski: Look I think we're our expectation is to enter into negotiations with the MA plans, while <unk> is still.

Les Sulewski: And then just kind of your ability to foresee the utilization tracking I know, you're just kind of shed some insight into customers, providing some of that but.

Joseph Todisco: Yeah, no, thanks, Greg. You know, the macro-level issues right now that are kind of going on, call it, you know, worldwide, whether it's tariff-related or other kind of supply chain constraints aren't really an issue for us, right? Our lumpiness was entirely, right, or largely caused by, you know, just a price incentive that a customer had to kind of move some inventory or take a little bit of inventory earlier, right? And they're working through that inventory now, which is why we, you know, encouraged, you know, investors to look at the first half of the year kind of as a lump sum period.

Les Sulewski: Still enforced and weather.

Speaker Change: Are you able to kind of differentiate what utilization versus inventory buildup, and then I have a follow up as well on reimbursement.

Les Sulewski: That ends up impacting reimbursement in year three of your four we don't know yet I don't know that Theres a lot of precedent for four to depo launches entering into direct contracts with MA plans, So thats something were.

Speaker Change: Alright, Thanks last one and I'll try and triangle through these.

Speaker Change: So when we talk about U S renal care and kind of order rates normalizing.

Les Sulewski: We're looking to engage and obviously our real world evidence study is a big piece.

Les Sulewski: Of the data that we're hoping to utilize.

Speaker Change:

Speaker Change: And I think what you're really asking is kind of what's the what's the runway for growth over over the back part of the year I think there's some runway for growth I think we're probably more a little bit more than 80%.

Les Sulewski: For those negotiations.

Les Sulewski: What I can say now.

Les Sulewski: Certainly promising when we look at our claims data about 40% of our claims are.

Joseph Todisco: From an inventory prep standpoint, we've got a significant amount of active pharmaceutical ingredient on hand for both heparin and tyrolidine that should or will cover not only, you know, our current demand run rate for more than a year, but also a good amount of should we need to, to support, you know, any increased customer demand. We've also got a good runway of finished dosage inventory manufactured. We have two finished dosage manufacturers that have been qualified by the FDA, so we have some flexibility there. So overall, inventory is really not a constraint for us or something that I would foresee causing any fluctuations in our earnings.

Les Sulewski: Currently Ma.

Les Sulewski: M&A plans.

Speaker Change: Implemented right within the kind of the eligible patient population based on the criteria. They set up but I do think there's still opportunity and there's always new patients that come in and begin die at dialysis that meet the criteria. So.

Les Sulewski: Number of plans currently.

Les Sulewski: Providing reimbursement so that's from our view all all positive.

Les Sulewski: Great and just maybe last one on that fund up to 40% and what would you expect that to grow to or change to by the end of your T. Deeper coverage. Thank you well I wouldn't expect it to grow past 50 50 right because.

Speaker Change: I'd say with the other mid sized customers is a little bit more more runway I would say for growth. We've obviously implemented.

Speaker Change: More recently right. So we're still kind of in the ramping phase I think.

Les Sulewski: About 50% of of the Medicare based ESR D population. Most of these patients are Medicare it's about half fee for service traditional or and have MMA. So that's about what I would expect so as I said I think it's pretty positive that about 40% of our claims are our Medicare advantage and then that combined with a little bit of commercial and probably some <unk>.

Speaker Change: With both IRC in Dci as well as with <unk>.

Speaker Change: A number of a number of the smaller customers on utilization tracking I would say is at least with U S renal care, which and I'll correct. The number I gave before I think for this quarter was 78% of a.

Speaker Change: Shipments in the first quarter or of revenue in the first quarter.

Kate: Kate as well.

Gregory Renza: Got it. It makes sense. Congrats again. I'll hop back in. Thanks, Greg.

Speaker Change: Got it okay. That's helpful. Thank you.

Speaker Change: We do have pretty good visibility as to what is <unk>.

Les Sulewski: Yeah.

Operator: Thank you.

Les Sulewski: Perfect. Thank you.

Speaker Change: Utilization versus what is what is inventory and thats.

Roanna Ruiz: The next question comes from Roanna Ruiz from Lear Inc. Partners. Please go ahead. Hey, morning, everyone. So a couple for me.

Speaker Change: A reminder to all the participants if you wish to register for a question you May Press Star then one on your telephone keypad.

Speaker Change: The basis for which we've we've amended our guidance and now we're guiding towards the upper end of our range.

Speaker Change: Our next question comes from Serge Belanger from Needham and company. Please go ahead.

Joseph Todisco: First one, could you talk a bit more about the main drivers behind the 1Q revenue number, especially given the successful implementation? I was curious, did some of that strength come from U.S. Renal or some of the small and medium dialysis centers? And what metrics are giving you more confidence to point to the top end of your first half guidance? Thanks, Roanna. Look, I think we have a number in the queue exactly what percentage, you know, our customers or top customer accounts for. I do believe that US Renal in the first quarter was still more than 80% of shipments.

Speaker Change: Got it very helpful on the reimbursement front. So now maybe you're kind of looking ahead.

Speaker Change: Medicare advantage being a bigger share.

Serge Belanger: Hi, good morning.

Speaker Change: Can we kind of I guess assume theres a potential for a reimbursement negotiation with Medicare advantage and the early phases of the TDAP a period or is this more of a kind of a concrete decision that will coincide with.

Speaker Change: Joe just a couple of questions first on the inpatient segment.

Speaker Change: You've now been in that market for a year I think since last April. So just curious how you think about the overall opportunity a year later.

Speaker Change: End of <unk> coverage.

Speaker Change: How much of the business.

Speaker Change: It could represent relative to the outpatient segment and then secondly.

Speaker Change: Look I think we're our expectation is to enter into negotiations with the MA plans, while to DAP is still.

Speaker Change: Are there any efforts.

Speaker Change: Still enforce rate and weather.

Speaker Change: To modify or improve to that reimbursement process process at this point. Thanks.

Speaker Change: That ends up impacting reimbursement in year three of your four we don't know yet I don't know that Theres a lot of precedent for four to dapple launches entering into direct contracts with MA plans, So thats something were.

Speaker Change: Thanks.

Joseph Todisco: So, obviously, it is a large driver. They're currently our, you know, our biggest anchor customer. But we did see good growth in the first quarter, as I said, with small customers, with hospitals, you know, and the inpatient side. I think first quarter overall was around 3% of shipments, but a little bit larger percentage of dollars, right? There's a little bit better pricing in the hospital inpatient segment at this point of time.

Sarah: Thanks, Sarah authentic first question first.

Speaker Change: Yes, we did we did launch in the inpatient segment last year, but as we've talked about on prior calls, it's a really long ramp right to get the product in front of TNT Committee to get through PNC Committee right build champions within these institutions a lot of them very academic minded want to see what's going on in other institutions. So it's taken it's taken a long time.

Speaker Change: We're looking to engage and obviously our real world evidence study is a big piece of.

Speaker Change: The data that we're hoping to utilize.

Speaker Change: Those negotiations.

Speaker Change: I can say now that's certainly promising when we look at our claims data about 40% of our claims are.

Joseph Todisco: You know, when we talk about guidance and kind of our thoughts around it being at the top end of the range, we're doing a pretty good analysis now on inventory, certainly at US Renal Care. But a couple of the other customers have begun sharing inventory reports. We have a little bit of visibility now into what their weekly dispensing utilization is. So, you know, we're basically making a projection, right, of what they have on hand, what the rundown is going to be, and what we think new orders are going to be over the next couple of weeks.

Speaker Change: Currently MAA.

Sarah: To kind of build a little bit of critical mass there and now we're starting to see.

Speaker Change: Emma plans, a large number of plans currently providing reimbursement so that's from our view all all positive.

Speaker Change: Some progress and now we've got a dedicated inpatient team.

Speaker Change: Debt is now three weeks I think in the field and fully operational.

Speaker Change: Great and just maybe last one on that fund of 40% and what would you expect that to grow to or change to by the end of year TDAP a coverage.

Speaker Change: We do think we've got good runway, there and an opportunity to grow the business.

Speaker Change: What what it could grow to as a percentage of our business is kind of hard to pin down.

Speaker Change: Well I wouldn't expect it to grow past 50, 50, right because the MAA is about 50% of of the Medicare based ESR D. Population. Most of these patients are Medicare it's about half fee for service traditional or and have MMA. So that's about what I would expect so as I said I think it's pretty positive that about 40% of our clients.

Speaker Change: Overall, if you look at in terms of the total market opportunity the Tam of about 10% of of the unit volume flows through inpatient.

Speaker Change: As we said.

Speaker Change: As we said in the past, we think theres, a little bit more durable pricing, perhaps on the inpatient side that could lead to a higher dollar dollar value.

Roanna Ruiz: Got it.

Roanna Ruiz: And one last follow-up for me.

Joseph Todisco: I was also curious, thinking about the outstanding LDO, any updates there on what you're thinking about or what they might want to see to get more comfortable or just implement more using Defendcast and enter a contract, et cetera? Yeah. You know, as I said to Greg, I'm not going to speak for them in terms of what they might or might not be looking at in terms of implementation or timing. I can only speak to the questions that we're being asked and what we're being asked to provide. You know, essentially are all of the same things that we've provided to other customers, right, as we've ramped up toward implementation.

Speaker Change: <unk>, our Medicare advantage and then that's combined with a little bit of commercial and probably some Medicaid as well.

Speaker Change: What I had mentioned that.

Speaker Change: We essentially for April.

Speaker Change: Got it okay. That's helpful. Thank you.

Speaker Change: We kind of doubled our rate of shipments right from 3% of our shipments in the first quarter and patients about 6%, so far leading into in the second quarter.

Speaker Change: Perfect. Thank you.

Speaker Change: A reminder to all the participants if you wish to register for a question you May Press Star then one on your telephone keypad.

Speaker Change: As a percentage of our overall business it will really depend upon.

Our next question comes from Serge Belanger from Needham and company. Please go ahead.

Speaker Change: The timing and scale of bringing on new customers, specifically, if an LDL customer comes on in and is driving higher volumes inpatient will be a smaller percentage of the business, but that doesn't necessarily mean that it's not going to be material or meaningful right as a growth driver. So it's hard to kind of pin down.

Serge Belanger: Hi, good morning.

Speaker Change: Joe just a couple of questions first on the inpatient segment.

Speaker Change: You've now been in that market for for a year I think since last April. So just curious how you think about the overall opportunity a year later.

Roanna Ruiz: So, you know, as I get more information, I'm certainly going to update investors. But, you know, right now, as I said, I'm comfortable and we're optimistic that, you know, we're on the timelines that we've communicated previously. Got it. Thank you.

Speaker Change: A number of what we expect it to be.

Speaker Change: It really depends on a lot of variables.

Speaker Change: How much of the business.

Speaker Change: It could represents a relative to the outpatient segment and then secondly.

Speaker Change: Just kind of changing gears onto data in terms of efforts to modify to dapper I'd say, there's a few efforts that are currently ongoing.

Speaker Change: Are there any effort.

Speaker Change: To modify or improve the reimbursement process process at this point.

Speaker Change: One of the things that we're keeping an eye on in July that the proposed rule for 2026 should come out from CMS.

Leszek Sulewski: Your next question comes from Les Sulewski from Truist Securities. Please go ahead. Good morning. Thank you for taking my questions, and then congrats on the progress, guys. So, Joe, perhaps maybe you can talk about U.S. Reno, start there. You expect the order rates to normalize. I guess maybe provide us a sense of what patient pool or percent of their patient pool is on the FENCAF. Are there additional cohorts that can be further implemented? And then in regards to other customers, have they notified you on when they start, maybe will start taking in shipments? And then just kind of your ability to foresee the utilization tracking.

Speaker Change: <unk>.

Speaker Change: Thanks Sarah.

Speaker Change: Stakeholders have submitted.

Speaker Change: The first question first.

Speaker Change: Yes, we did we did launch in the inpatient segment last year, but as we've talked about on prior calls, it's a really long ramp right to get the product in front of TNT Committee to get through PNC Committee right build champions within these institutions a lot of them very academic minded want to see what's going on in other institutions. So it's taken it's taken a long time to.

Speaker Change: Large number of comments in terms of potential changes to the Napa I think we're hopeful to see something in that in that proposed rule for next year that.

Speaker Change: We would view as an improvement for <unk> and we're keeping an eye on that.

Speaker Change: Separately there are some legislative initiatives that are that are going on with stakeholders working with members of the hill.

Speaker Change: Kind of build a little bit of critical mass there and now we're starting to see some.

Speaker Change: Hopefully get a bill brought forward.

Speaker Change: Later, this year that would that would qualify to tap to that band.

Speaker Change: Some progress and now we've got a dedicated inpatient team.

Speaker Change: In La and also make make improvements to the Napa.

Speaker Change: Debt is now three weeks I think in the field and fully operational so were.

Speaker Change: But legislation as always.

Joseph Todisco: I know you kind of shared some insights into customers providing some of that, but are you able to kind of differentiate what's utilization versus inventory buildup?

Speaker Change: We do think we've got good runway, there and an opportunity to grow the business.

Speaker Change: An uphill fight certainly in this Congress, but there is a lot of I'd say momentum amongst stakeholders want to see.

Speaker Change: What what it could grow to as a percentage of our business is kind of hard to pin down.

Joseph Todisco: And then I have a follow-up as well on reimbursement. All right. Thanks, Les. I'm going to try and go all through these. So, when we talk about U.S. renal care and kind of order rates normalizing, you know, and I think what you're really asking is kind of what's the runway for growth over the back part of the year. I think there's some runway for growth. I think we're probably a little bit more than 80 percent implemented, right, within the kind of the eligible patient population based on the criteria they set up. But I do think there's still opportunity and there's always new patients, right, that come in and begin dialysis that meet the criteria.

Speaker Change: Change its dapper to make it either longer in duration and more sustainable over time and.

Speaker Change: Overall, if you look at in terms of the total market opportunity the Tam of about 10% of of the unit volume flows through inpatient.

Speaker Change: Perhaps better drive utilization of innovative therapies.

Speaker Change: As we said.

Speaker Change: As we said in the past, we think theres, a little bit more durable pricing, perhaps on the inpatient side that could lead to a higher dollar dollar value.

Speaker Change: Thanks.

Speaker Change: Thank you.

Speaker Change: Now I'll turn the conference over to Dan Ferry for written questions from the audience.

Speaker Change: And I had mentioned that we essentially for April.

Dan Ferry: Thank you operator.

Speaker Change: So we do have one written questions from the audience here.

Speaker Change: We kind of doubled our rate of shipments right from 3% of our shipments in the first quarter and patients about 6% so far leading into.

Speaker Change: Can you provide any feedback from providers for customers.

Speaker Change: The second quarter.

Speaker Change: On their experience with defend cap to date.

Joseph Todisco: So, you know, I'd say with the other kind of midsize customers, there's a little bit more runway, I'd say, for growth. We've obviously implemented more recently, right, so we're still kind of in the ranting phase, I think, with both IRC and DCI as well as with a number of the smaller customers. On utilization tracking, I would say at least with U.S. renal care, which, and I'll correct the number I gave before, I think for this quarter was 78 percent of shipments in the first quarter or of revenue in the first quarter, we do have pretty good visibility as to what is utilization versus what is inventory.

Speaker Change: As a percentage of our overall business it will really depend upon the.

Speaker Change: Yeah.

Speaker Change: The timing and scale of bringing on new customers, specifically, if an LDL customer comes on and it is driving higher volumes inpatient will be a smaller percentage of the business, but that doesn't necessarily mean that it's not going to be material or meaningful right as a growth driver. So it's hard to kind of pin down.

Speaker Change: Okay.

Speaker Change: That's a good question, Dan I'm going to I'm going to actually ask Liv to kind of touch on that from a medical standpoint in terms of what we've what we've heard and seen from customers, but sure. So I would say our customer feedback has been very positive overall, our clinical implementation and excellent team work really closely with our customers to ensure a smooth.

Speaker Change: A number of what we expect it to be.

Speaker Change: It really depends on a lot of variables.

Speaker Change: Transitioning to defend cap.

Speaker Change: I think many of them surprised how easily defend cath fits into their current workflow and the clinicians overall has been pretty quick to adopt and introduce patients.

Speaker Change: Just kind of changing gears onto dapper in terms of efforts to modify the dapper I'd say, there's a few efforts that are currently ongoing.

Speaker Change: One of the things that we're keeping an eye on in July that the proposed rule for 2026 should come out from CMS.

Speaker Change: And I also think our reimbursement support services with perspective have been instrumental in supporting customers with the nuances of <unk> an end cap claims taking that unknown factor out of the aspect. So overall, it's been really positive.

Leszek Sulewski: And that's the basis for which we've amended our guidance and now we're guiding toward the upper end of our Got it. Very, very helpful.

Speaker Change: Stakeholders have submitted.

Speaker Change: A large number of comments in terms of potential changes to that but I think we're hopeful to see something in that in that proposed rule for next year that that we would view as an improvement for DAP and we're keeping an eye on that.

Leszek Sulewski: On the reimbursement front, so now maybe kind of looking ahead, you know, Medicare Advantage being a bigger share, can we kind of, I guess, assume there's a potential for a reimbursement negotiation with Medicare Advantage in the early phases of the TDAPA period, or is this more of a kind of a concrete decision that will coincide with end of TDAPA coverage? Look, I think we're, our expectation is to enter into negotiations with the MA plans, you know, while TODAPA is still, still in force, right, and whether that ends up impacting, you know, reimbursement in year three or year four, you know, we don't know yet.

Speaker Change: Thanks, a lot thanks Louis.

Speaker Change: Thanks.

Speaker Change: Alright.

Speaker Change: Separately there are some legislative initiatives that are that are going on with stakeholders working with members of the hill.

Speaker Change: So with that said I don't have any other further questions from the audience.

Speaker Change: With that operator.

Speaker Change: To hopefully get a bill brought forward.

Speaker Change: All set.

Speaker Change: Later, this year that would that would qualify to tap to that band.

Speaker Change: Operator, you May you may close the call.

Speaker Change: Perfect. Thank you well. Thank you. Thank you everybody.

Speaker Change: In La and also make make improvements to the Napa.

Speaker Change: But legislation as always.

Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Speaker Change: An uphill fight certainly in this Congress, but there is a lot of I'd say momentum amongst stakeholders want to see.

Speaker Change: Changes to the dapper to make it either longer duration more sustainable over time and.

Leszek Sulewski: I don't know that there's a lot of precedent for, for TODAPA launches entering into direct contracts with MA plans, so that's something we're, we're looking to engage in. Obviously, our real-world evidence study is a big piece of the data that we're hoping to utilize, you know, for those negotiations. What I could say now that's, that's certainly promising when we look at our claims data, about 40% of our claims are currently MA, you know, MA plans, a large number of plans currently providing reimbursement, so that's, from our view, all, all positive. Great. And just maybe last one on that front, the 40%.

Speaker Change: Perhaps better drive utilization of innovative therapies.

Speaker Change: Thanks.

Speaker Change: Thank you.

Dan Ferry: Now I'll turn the conference over to Dan Ferry for written questions from the audience.

Speaker Change: Thank you operator.

Speaker Change: We do have one written questions from the audience here.

Speaker Change: Can you provide any feedback from providers our customers.

Leszek Sulewski: What would you expect that to grow to or change to by the end of your Tdapr coverage? Thank you. Well, I wouldn't expect it to grow past 50-50, right, because MA is about 50% of the Medicare-based ESRD population. Most of these patients are Medicare. It's about half fee-for-service traditional and half MA. So that's about what I would expect. So that's why I said I think it's pretty positive that about 40% of our claims are Medicare Advantage. And that's combined with a little bit of commercial and probably some Medicaid as well. Got it. Okay, that's helpful.

Speaker Change: On their experience with the sudden cap to date.

Speaker Change: Yeah.

Speaker Change: Okay.

Speaker Change: That's a good question Dan.

Speaker Change: I actually asked.

Speaker Change: Liz to kind of touch on that from a medical standpoint in terms of what we've what we've heard and seen from customers.

Speaker Change: Sure. So I would say our customer feedback has been very positive overall, our clinical implementation and excellence team work really closely with our customers to ensure a smooth transition to defend cap.

Speaker Change: I think many of them surprised how easily defend cath fits into their current workflow and the clinicians overall has been pretty quick to adopt and introduce patients.

Leszek Sulewski: Thank you. Perfect, thank you.

Speaker Change: And I also think our reimbursement support services with perspective have been instrumental in supporting customers with the nuances of teed up at an end cap claims taking that unknown factor out of the aspect. So overall, it's been really positive.

Operator: A reminder to all the participants, if you wish to register for a question, you may press star then 1 on your telephone keypad.

Serge Belanger: Our next question comes from Serge Belanger from Needham and Company. Please go ahead. Hi, good morning. Joe, I guess a couple questions first on the inpatient segment. You've now been in that market for a year, I think since last April. So just curious how you think about the overall opportunity a year later and, you know, how much of the business it could represent relative to the outpatient segment. And then secondly, are there any efforts to modify or improve to that reimbursement process at this point? Thanks. Thanks, Serge.

Speaker Change: Thanks, a lot thanks Louis.

Speaker Change: Thanks.

Speaker Change: Alright.

Speaker Change: So with that said I don't have any other further questions from the audience.

Speaker Change: With that operator.

Speaker Change: All set.

Speaker Change: Operator, you May you may close the call perfect. Thank you well. Thank you. Thank you everybody.

Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Speaker Change: Okay.

Speaker Change: [noise].

Joseph Todisco: I'll take the first question first. You know, yes, we did we did launch in the inpatient segment last year, but as we've talked about on prior calls, it's a really long ramp, right, to get the product in front of P&T committee, get through P&T committee, right, build champions within these institutions. A lot of them are very academic minded and want to see what's going on in other institutions. So, it's taken a long time to kind of build a little bit of critical mass there. And now we're starting to see some progress. And now we've got a dedicated inpatient team that is now three weeks, I think, in the field and fully operational.

Joseph Todisco: So, we're, you know, we do think we've got a good runway there and an opportunity to grow the business. You know, what what it could grow to as a percentage of our business is kind of hard to pin down. You know, overall, if you look at in terms of the total market opportunity, the TAM, about 10% of of the unit volume flows through inpatient. You know, as we said, as we said in the past, we, you know, we think there's a little bit more durable pricing, perhaps, on the inpatient side that could lead to a higher dollar value, you know, and I had mentioned that, you know, we essentially, for April, you know, we kind of doubled our rate of shipments, right, from, you know, it was 3% of our shipments in the first quarter, inpatients about 6% so far, leading into in the second quarter.

Joseph Todisco: You know, as a percentage of our overall business, it will really depend upon, right, the timing and scale of bringing on new customers, right? Specifically, if an LDO customer comes on and is driving higher volumes, inpatient will be a smaller percentage of the business, but that doesn't necessarily mean that it's not going to be material or meaningful, right, as a growth driver. So it's hard to kind of pin down, you know, a number of what we expect it to be.

Joseph Todisco: It really depends on a lot of variables.

Joseph Todisco: Just kind of changing gears on to DAPA in terms of efforts to modify to DAPA. I'd say there's a few efforts that are currently ongoing. You know, one of the things that we're keeping an eye on in July, the proposed rule for 2026 should come out from CMS. Stakeholders have submitted a large number of comments in terms of potential changes to DAPA. I think we're hopeful to see something in that proposed rule for next year that we would view as an improvement for DAPA. We're keeping an eye on that. Separately, there are some legislative initiatives that are going on with stakeholders working with members of the Hill to hopefully get a bill brought forward later this year that would codify to DAPA in law and also make improvements to the DAPA.

Serge Belanger: But, you know, legislation is always, you know, an uphill fight, certainly in this Congress, but there is a lot of, I'd say, momentum among stakeholders that want to see changes to DAPA to make it either longer in duration, more sustainable over time, and, you know, perhaps, you know, better drive utilization of innovative therapies. Thanks. Thank you.

Dan Ferry: Now I'll turn the conference over to Dan Ferry for written questions from the audience. Thank you, operator. Jill, we do have one written question from the audience here.

Joseph Todisco: Can you provide any feedback from providers or customers? on their experience with DefendCast to date. Okay. That's a good question, Dan.

Elizabeth Masson: You know, I'm going to actually ask Liz to kind of touch on that from a medical standpoint in terms of what we've heard and seen from customers. Go ahead. Sure. So, I would say our customer feedback has been very positive overall. Our clinical implementation and excellence team works really closely with our customers to ensure a smooth transition to DefendCath. I think many have been surprised how easily DefendCath fits into their current workflow, and the clinicians overall have been pretty quick to adopt and introduce patients. I also think our reimbursement support services with Prospectus have been instrumental in supporting customers with the nuances of TDAPA and NTAP claims, taking that unknown factor out of the aspect.

Elizabeth Masson: So, overall, it's been really positive. Thanks, Les. All right. Thanks, Les. Thank you.

Dan Ferry: Joe, with that said, I don't have any other further questions from the audience. With that, I'd offer, that's it. operator, you may close the call. Perfect. Thank you. Well, thank you. Thank you, everybody. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.