NASDAQ:CRMD CorMedix Q1 2025 Earnings Report $12.26 -0.03 (-0.24%) Closing price 03:59 PM EasternExtended Trading$12.26 0.00 (-0.01%) As of 04:04 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast CorMedix EPS ResultsActual EPS$0.30Consensus EPS $0.25Beat/MissBeat by +$0.05One Year Ago EPS-$0.25CorMedix Revenue ResultsActual Revenue$39.08 millionExpected Revenue$38.90 millionBeat/MissBeat by +$182.00 thousandYoY Revenue GrowthN/ACorMedix Announcement DetailsQuarterQ1 2025Date5/6/2025TimeBefore Market OpensConference Call DateTuesday, May 6, 2025Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by CorMedix Q1 2025 Earnings Call TranscriptProvided by QuartrMay 6, 2025 ShareLink copied to clipboard.PresentationSkip to Participants Operator00:00:00Good day, and welcome to the CorMedix Inc. First Quarter twenty twenty five Financial Results Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Dan Ferry, LifeSci Advisors. Operator00:00:37Please go ahead. Dan FerryManaging Director at LifeSci Advisors, LLC00:00:40Good morning and welcome to the CorMedix first quarter twenty twenty five earnings conference call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix. He is joined by Doctor. 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 Aaron Mystery, EVP and Chief Commercial Officer. Dan FerryManaging Director at LifeSci Advisors, LLC00:01:07Before we begin, I would like to remind everyone that during the call, management may make what are known as forward looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are statements other than statements of historical fact regarding management's expectations, beliefs, goals and plans about the company's prospects and future financial position. Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risks and uncertainties described in greater detail in CorMedix's filings with the SEC, which are available free of charge at the SEC's website or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in these forward looking statements, 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. Dan FerryManaging Director at LifeSci Advisors, LLC00:02:04During 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 eight ks filed with the SEC. This information is available on the Investor Relations section of CorMedix's website. 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. Dan FerryManaging Director at LifeSci Advisors, LLC00:02:36Thanks, Dan. Joe TodiscoChief Executive Officer at CorMedix00:02:38Good morning, everyone, and thank you for joining us on this call. CorMedix continues to have solid momentum with the launch of DefendCath, highlighted by strong first quarter net sales of $39,100,000 in line with our earlier preannounced results. Adjusted EBITDA for the first quarter of twenty three point six million dollars was slightly above our earlier preannouncement. We continue to see steady utilization growth with existing anchor customer U. S. Joe TodiscoChief Executive Officer at CorMedix00:03:05Renal 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. In early April, we updated our net revenue guidance for DEFENCATH sales to existing customers for the first half of the year and we guided to a range of $62,000,000 to $70,000,000 which implied second quarter twenty twenty five net revenue guidance of $23,000,000 to $31,000,000 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 $70,000,000 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. Joe TodiscoChief Executive Officer at CorMedix00:04:14S. Renal Care, in which they purchased a few additional weeks of inventory in both the fourth quarter of twenty twenty four and first quarter of twenty twenty five 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. Joe TodiscoChief Executive Officer at CorMedix00:04:36To that extent, we do anticipate utilization growth in the back half of twenty twenty five 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. 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 twenty twenty five implementation start. We intend to update investors once we have more definitive timeline from the customer. Joe TodiscoChief Executive Officer at CorMedix00:05:21Turning 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. Focusing now on our clinical developments, we have begun our Phase three clinical study for the reduction of central line associated bloodstream infections or CLABSIs in adult patients receiving total parenteral 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 twelve 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 twenty twenty six or beginning of twenty twenty seven. Joe TodiscoChief Executive Officer at CorMedix00:06:29We 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 Tyroldine and heparin catheter lock solution in the late twenty twenty seven to early twenty twenty eight timeframe. And we estimate annual peak sales potential in this indication to be in the range of 150,000,000 to $200,000,000 based off a total addressable market size of $500,000,000 to $750,000,000 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. Joe TodiscoChief Executive Officer at CorMedix00:07:21S. Renal Care has eclipsed two thousand patients and will hit its midpoint in July. Our hope with this study in which we expect to evaluate patient outcomes over a twenty four month period is to generate real world evidence around the impact of DEFENCATH 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. Data from this study will be critical to our objective of making DefenCath standard of care catheter lock in the outpatient hemodialysis setting. In addition to our adult TPN and real world evidence studies, our study of DEFENCATH in the pediatric hemodialysis population is on target to begin in the third quarter of this year. Joe TodiscoChief Executive Officer at CorMedix00:08:08And 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 CVC is now live. I would now like to turn the call over to Matt to discuss the company's first quarter financial results and financial position. Matt? Matt DavidExecutive VP & CFO at CorMedix00:08:31Thanks, Joe, and good morning, everyone. Matt DavidExecutive VP & CFO at CorMedix00:08:33I am Matt DavidExecutive VP & CFO at CorMedix00:08:34pleased to be here today to provide an overview of our first quarter twenty twenty five 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 03/31/2025. 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 twenty twenty five financial results, our net revenue for the first quarter of twenty twenty five amounted to $39,100,000 CorMedix achieved profitability for the first quarter as our net income was $20,600,000 or $0.32 per share compared with a net loss of $14,500,000 or $0.25 per share in the first quarter of twenty twenty four. The net income recognized in 2025 was driven by the gross profits associated with the net sales of DefenCap. Matt DavidExecutive VP & CFO at CorMedix00:09:29Operating expenses in the first quarter of twenty twenty five increased approximately 9% to $17,400,000 compared with $15,900,000 in the first quarter of twenty twenty four. R and D expense increased by approximately 281% to $3,200,000 from approximately $800,000 in the first quarter of twenty twenty four, driven by the increase in personnel and clinical trial services in support of our ongoing clinical programs. Selling and marketing expense decreased 29% to $4,500,000 in the first quarter of twenty twenty five compared with $6,300,000 in the first quarter of twenty twenty four. G and A expense increased 11% to $9,700,000 in the first quarter of twenty twenty five versus $8,700,000 in the first quarter of twenty twenty four. 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. Matt DavidExecutive VP & CFO at CorMedix00:10:33We expect those costs to be normalized for the second quarter. The increase in G and 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 twenty twenty five of 19,700,000.0 compared with net cash used in operations of $17,300,000 in the first quarter of twenty twenty four. The increase is driven by our net income for the period versus a net loss in the comparison period. The company has cash and cash equivalents of $77,500,000 as of 03/31/2025. Matt DavidExecutive VP & CFO at CorMedix00:11:12As described previously, we are guiding to 2025 cash operating expenses of approximately $72,000,000 to 78,000,000 The increase over 2024 spending levels is expected to be largely driven by an increase in R and D spending on our clinical initiatives. I will now turn the call back over to Joe for closing remarks. Joe? Joe TodiscoChief Executive Officer at CorMedix00:11:33Thanks, Matt. CorMedix is working diligently on all fronts to increase our existing customer base as well as expanding its DEFENCATH to new therapeutic indications. I appreciate everyone's continued support in CorMedix and I'm happy to take questions. Operator00:11:49We will now begin the question and answer session. Our first question comes from Gregory Renza from RBC Capital. Please go ahead. Gregory RenzaSenior Biotechnology Analyst at RBC Capital Markets00:12:25Great. 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 progress. Gregory RenzaSenior Biotechnology Analyst at RBC Capital Markets00:12:38Just curious if you could just provide how that has how your perceptions and your engagement there has evolved since we've last spoken in 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. I know that's longer term, but just want to see how you're driving to support those goals. Joe TodiscoChief Executive Officer at CorMedix00:13:04No. Thanks, Greg. And with regard to the size of the population, I'm not to speak for 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 quite quickly should we need 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, right to initiate utilization. Joe TodiscoChief Executive Officer at CorMedix00:13:40Certainly nothing is ever set in stone, right with customers and we're waiting for an implementation date. But as I said, we're optimistic or cautiously optimistic as you want to take it. And we're ready to go as soon as they hopefully pull the trigger on a purchase order. Gregory RenzaSenior Biotechnology Analyst at RBC Capital Markets00:14:00Got it. And just maybe just on inventory control, obviously, this is the 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 selling into it and providing DefendCat to the Yes. Joe TodiscoChief Executive Officer at CorMedix00:14:37No, thanks, Greg. The macro level issues right now that are kind of going on, call it 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 largely caused by 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 encouraged investors to look at the first half of the year kind of as a lump sum period. From an inventory prep standpoint, we've got a significant amount of active pharmaceutical ingredient on hand for both heparin and tiraldine that should or will cover not only our current demand run rate for more than a year, but also a good amount of scale up should we need support any increased customer demand. Joe TodiscoChief Executive Officer at CorMedix00:15:36We'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. Gregory RenzaSenior Biotechnology Analyst at RBC Capital Markets00:16:00Got it. It makes sense. Congrats again. I'll hop back into the queue. Joe TodiscoChief Executive Officer at CorMedix00:16:04Thanks, Craig. Operator00:16:06Thank you. Your next question comes from Ruana Ruiz from Leerink Partners. Please go ahead. Roanna RuizSenior Managing Director, Biotechnology Analyst at Leerink Partners00:16:14Hey, morning everyone. So a couple from me. 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. Roanna RuizSenior Managing Director, Biotechnology Analyst at Leerink Partners00:16:29Renal 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? Joe TodiscoChief Executive Officer at CorMedix00:16:41Thanks, Rona. Look, I think we have a number in the queue exactly what percentage our customers or our top customer accounts for. I do believe that U. S. Renal in the first quarter was still more than 80% of shipments. Joe TodiscoChief Executive Officer at CorMedix00:16:59So obviously, is a large driver. They're currently our biggest anchor customer. But we did see good growth in the first quarter, as I said, with smaller customers, with hospitals. On 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. Joe TodiscoChief Executive Officer at CorMedix00:17:24When 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 U. S. 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 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. Roanna RuizSenior Managing Director, Biotechnology Analyst at Leerink Partners00:18:01Got it. And one last follow-up for me. 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 etcetera? Joe TodiscoChief Executive Officer at CorMedix00:18:20Yes. 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. Essentially are all of the same things that we provided to other customers, right, as we've ramped up toward implementation. So as I get more information, I'm certainly going update investors. Joe TodiscoChief Executive Officer at CorMedix00:18:48But right now, as I said, I'm comfortable and we're optimistic that we're on the timelines that we've communicated previously. Roanna RuizSenior Managing Director, Biotechnology Analyst at Leerink Partners00:18:59Got it. Thank you. Operator00:19:02Thank you. Your next question comes from Les Soulevskiy from Truist Securities. Please go ahead. Les SulewskiVP - Biotech Equity Research at Truist Securities00:19:12Good morning. Thank you for taking my questions and congrats on the progress guys. So Joe, perhaps maybe you can talk about U. S. Renal, start there. Les SulewskiVP - Biotech Equity Research at Truist Securities00:19:22You expect the order rates to normalize. I guess maybe can you provide a sense of what patient pool or percent of their patient pool is on DEFENCAF? Are there additional cohorts that could be further implemented? And then in regards to other customers, have they notified you on when they start they will start taking in shipments? And then just kind of your ability to foresee the utilization tracking. Les SulewskiVP - Biotech Equity Research at Truist Securities00:19:46I know you kind of shared some insights into customers providing you some of that, but, are you able to kind of differentiate what's utilization versus inventory buildup? And then I have a follow-up as well on reimbursement. Joe TodiscoChief Executive Officer at CorMedix00:19:59All right. Thanks, Les. I'm going try and go through these. So when we talk about U. S. Joe TodiscoChief Executive Officer at CorMedix00:20:06Renal Care and kind of order rates normalizing, 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 more a little bit more than 80% 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. So So I'd say with the other kind of midsized customers, there's a little bit more runway, I'd say, for growth. Joe TodiscoChief Executive Officer at CorMedix00:20:43We've obviously implemented more recently, right? So we're still kind of in the ramping phase, I think, with both IRC and DCI as well as with a number of the smaller customers. On utilization tracking, 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 first quarter. Joe TodiscoChief Executive Officer at CorMedix00:21:11We do have pretty good visibility as to what is utilization versus what is inventory. And that's the basis for which we've amended our guidance and now we're guiding toward the upper end of our range. Les SulewskiVP - Biotech Equity Research at Truist Securities00:21:26Got it. Very helpful. On the reimbursement front, so now maybe kind of looking ahead, 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? Joe TodiscoChief Executive Officer at CorMedix00:21:52Look, think we're our expectation is to enter into negotiations with EMA plans while TDAPA is still in force, right? And whether that ends up impacting reimbursement in year three or year four, we don't know yet. I don't know that there's a lot of precedent for TDAPA launches entering into direct contracts with MA plans. So that's something we're looking to engage in. Obviously, real world evidence study is a big piece of the data that we're hoping to utilize for those negotiations. Joe TodiscoChief Executive Officer at CorMedix00:22:24What I could say now that's certainly promising when we look at our claims data, about 40% of our claims are currently MA plans, a large number of plans currently providing reimbursement. That's from our view all positive. Les SulewskiVP - Biotech Equity Research at Truist Securities00:22:43Great. And just maybe last one on that front of 40%. What would you expect that to grow to or change to by the end of your TDAPA coverage? Joe TodiscoChief Executive Officer at CorMedix00:22:53Thank Joe TodiscoChief Executive Officer at CorMedix00:22:53you. Well, I wouldn't expect it to grow past fifty-fifty, right, because MA is about fifty percent 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. Joe TodiscoChief Executive Officer at CorMedix00:23:09So that's why I said, I think it's pretty positive that about forty percent of our claims are Medicare Advantage and that's combined with a little bit of commercial and probably some Medicaid as well. Les SulewskiVP - Biotech Equity Research at Truist Securities00:23:20Got it. Okay. That's helpful. Thank you. Operator00:23:26Perfect. Thank you. Our next question comes from Serge Belanger from Needham and Company. Please go ahead. Serge BelangerSenior Analyst at Needham & Company00:23:44Hi, good morning. Joe, I guess a couple of 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 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 Serge BelangerSenior Analyst at Needham & Company00:24:17point? Thanks. Joe TodiscoChief Executive Officer at CorMedix00:24:19Thanks, Sergio. I'll take the first question first. Yes, 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 and T committee, through P and T committee, right? Joe TodiscoChief Executive Officer at CorMedix00:24:34Build champions within these institutions. A lot of them 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. Joe TodiscoChief Executive Officer at CorMedix00:24:55So we're we do think we've got good runway there and an opportunity to grow the business. What it could grow to as a percentage of our business is kind of hard to pin down. Overall, if you look at in terms of the total market opportunity, the TAM about 10% of the unit volume flows through inpatient. As we said in the past, think there's a little bit more durable pricing perhaps on the inpatient side that could lead to a higher dollar value. And I had mentioned that we essentially for April, we kind of doubled our rate of shipments, right, from it was 3% of our shipments in the first quarter, inpatients about 6% so far leading into in the second quarter. Joe TodiscoChief Executive Officer at CorMedix00:25:45As 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 a number of what we expect it to be. It really depends on a lot of variables. Joe TodiscoChief Executive Officer at CorMedix00:26:15Just 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. Of the things that we're keeping an eye on in July, 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 TDAPA. Joe TodiscoChief Executive Officer at CorMedix00:26:46We'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. Legislation is always an uphill fight certainly in this Congress. But there is a lot of, I'd say, momentum amongst stakeholders that want to see changes to DAPA to make it either longer in duration, more sustainable over time and perhaps better drive utilization of innovative therapies. Serge BelangerSenior Analyst at Needham & Company00:27:31Thanks. Operator00:27:34Thank you. Now I'll turn the conference over to Dan Ferry for written questions from the audience. Dan FerryManaging Director at LifeSci Advisors, LLC00:27:42Thank you, operator. Joe, we do have one written question from the audience here. Can you provide any feedback from providers or customers on their experience with DefendCast to date? Joe TodiscoChief Executive Officer at CorMedix00:28:01Okay. That's a good question, Dan. 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. Liz HurlburtEVP, Chief Clinical Strategy and Operations Officer at CorMedix00:28:11Sure. 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, The clinicians overall have been pretty quick to adopt and introduce patients. I also think our reimbursement support services with Perspectus have been instrumental in supporting customers with the nuances of TDAPA and NTAP claims, taking that unknown factor out of the aspect. Liz HurlburtEVP, Chief Clinical Strategy and Operations Officer at CorMedix00:28:48Overall, it's been really positive. Dan FerryManaging Director at LifeSci Advisors, LLC00:28:54Thanks Liz. Joe TodiscoChief Executive Officer at CorMedix00:28:54Thanks Liz. Dan FerryManaging Director at LifeSci Advisors, LLC00:28:59Joe, with that said, I don't have any other further questions from the audience. That said, operator, you may close the call. Operator00:29:12Perfect. Thank you. Joe TodiscoChief Executive Officer at CorMedix00:29:13All right. Joe TodiscoChief Executive Officer at CorMedix00:29:13Well, thank everybody. Operator00:29:17The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read moreParticipantsExecutivesJoe TodiscoChief Executive OfficerMatt DavidExecutive VP & CFOLiz HurlburtEVP, Chief Clinical Strategy and Operations OfficerAnalystsDan FerryManaging Director at LifeSci Advisors, LLCGregory RenzaSenior Biotechnology Analyst at RBC Capital MarketsRoanna RuizSenior Managing Director, Biotechnology Analyst at Leerink PartnersLes SulewskiVP - Biotech Equity Research at Truist SecuritiesSerge BelangerSenior Analyst at Needham & CompanyPowered by Key Takeaways CorMedix reported Q1 2025 net sales of $39.1 million and adjusted EBITDA of $23.6 million, achieving profitability with net income of $20.6 million, and narrowed H1 2025 revenue guidance to approximately $70 million. Orders from anchor customer U.S. Renal Care are expected to normalize in Q3 2025, and overall utilization is forecast to grow in H2 2025 as new patients and smaller outpatient and inpatient customers adopt DefenCath. Planning and communication with the previously announced large dialysis operator (LDO) have intensified, leaving CorMedix optimistic about a mid-year 2025 implementation start pending final purchase orders. The inpatient segment is being scaled up with a fully operational field team and first orders shipped to VA facilities, driving inpatient shipments to over 6% of total in April—more than double Q1 levels. Clinical development is advancing, highlighted by a Phase 3 CLABSI trial in TPN patients (first dosing imminent, NDA targeted late 2026/early 2027), a 2,000-patient real-world evidence study on track for mid-July, and a pediatric hemodialysis study set to begin in Q3 2025 alongside a live expanded access program. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCorMedix Q1 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipants Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) CorMedix Earnings HeadlinesContrasting CorMedix (NASDAQ:CRMD) & Abbott Laboratories (NYSE:ABT)May 19 at 1:33 AM | americanbankingnews.comCorMedix Inc. to Participate in the RBC Global Healthcare ConferenceMay 15, 2025 | globenewswire.comVladimir Lenin was right…The Magnificent 7 could be in for a world of pain… And the insiders know it. It’s why Jeff Bezos just sold $3 billion of Amazon… it’s why Nvidia’s CEO just sold $713 million... and it’s why Zuckerberg just sold $1.3 billion in Meta stock. The financial establishment doesn’t want you to know about this… but a controversial new documentary just pulled back the curtain and exposed what’s really going on. It’s called The Final Frontier.May 22, 2025 | Porter & Company (Ad)CorMedix Inc. (CRMD): Among Billionaire Paul Singer’s Stock Picks with Huge Upside PotentialMay 10, 2025 | finance.yahoo.comCorMedix Inc. (CRMD): Among Billionaire Paul Singer’s Stock Picks with Huge Upside PotentialMay 9, 2025 | insidermonkey.comAnalysts Just Shipped A Substantial Upgrade To Their CorMedix Inc. (NASDAQ:CRMD) EstimatesMay 8, 2025 | finance.yahoo.comSee More CorMedix Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like CorMedix? Sign up for Earnings360's daily newsletter to receive timely earnings updates on CorMedix and other key companies, straight to your email. Email Address About CorMedixCorMedix (NASDAQ:CRMD), a biopharmaceutical company, focuses on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases in the United States. Its lead product candidate is DefenCath, an antimicrobial catheter lock solution to reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure. The company was formerly known as Picton Holding Company, Inc. and changed its name to CorMedix, Inc. in January 2007. 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PresentationSkip to Participants Operator00:00:00Good day, and welcome to the CorMedix Inc. First Quarter twenty twenty five Financial Results Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Dan Ferry, LifeSci Advisors. Operator00:00:37Please go ahead. Dan FerryManaging Director at LifeSci Advisors, LLC00:00:40Good morning and welcome to the CorMedix first quarter twenty twenty five earnings conference call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix. He is joined by Doctor. 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 Aaron Mystery, EVP and Chief Commercial Officer. Dan FerryManaging Director at LifeSci Advisors, LLC00:01:07Before we begin, I would like to remind everyone that during the call, management may make what are known as forward looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are statements other than statements of historical fact regarding management's expectations, beliefs, goals and plans about the company's prospects and future financial position. Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risks and uncertainties described in greater detail in CorMedix's filings with the SEC, which are available free of charge at the SEC's website or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in these forward looking statements, 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. Dan FerryManaging Director at LifeSci Advisors, LLC00:02:04During 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 eight ks filed with the SEC. This information is available on the Investor Relations section of CorMedix's website. 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. Dan FerryManaging Director at LifeSci Advisors, LLC00:02:36Thanks, Dan. Joe TodiscoChief Executive Officer at CorMedix00:02:38Good morning, everyone, and thank you for joining us on this call. CorMedix continues to have solid momentum with the launch of DefendCath, highlighted by strong first quarter net sales of $39,100,000 in line with our earlier preannounced results. Adjusted EBITDA for the first quarter of twenty three point six million dollars was slightly above our earlier preannouncement. We continue to see steady utilization growth with existing anchor customer U. S. Joe TodiscoChief Executive Officer at CorMedix00:03:05Renal 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. In early April, we updated our net revenue guidance for DEFENCATH sales to existing customers for the first half of the year and we guided to a range of $62,000,000 to $70,000,000 which implied second quarter twenty twenty five net revenue guidance of $23,000,000 to $31,000,000 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 $70,000,000 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. Joe TodiscoChief Executive Officer at CorMedix00:04:14S. Renal Care, in which they purchased a few additional weeks of inventory in both the fourth quarter of twenty twenty four and first quarter of twenty twenty five 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. Joe TodiscoChief Executive Officer at CorMedix00:04:36To that extent, we do anticipate utilization growth in the back half of twenty twenty five 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. 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 twenty twenty five implementation start. We intend to update investors once we have more definitive timeline from the customer. Joe TodiscoChief Executive Officer at CorMedix00:05:21Turning 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. Focusing now on our clinical developments, we have begun our Phase three clinical study for the reduction of central line associated bloodstream infections or CLABSIs in adult patients receiving total parenteral 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 twelve 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 twenty twenty six or beginning of twenty twenty seven. Joe TodiscoChief Executive Officer at CorMedix00:06:29We 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 Tyroldine and heparin catheter lock solution in the late twenty twenty seven to early twenty twenty eight timeframe. And we estimate annual peak sales potential in this indication to be in the range of 150,000,000 to $200,000,000 based off a total addressable market size of $500,000,000 to $750,000,000 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. Joe TodiscoChief Executive Officer at CorMedix00:07:21S. Renal Care has eclipsed two thousand patients and will hit its midpoint in July. Our hope with this study in which we expect to evaluate patient outcomes over a twenty four month period is to generate real world evidence around the impact of DEFENCATH 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. Data from this study will be critical to our objective of making DefenCath standard of care catheter lock in the outpatient hemodialysis setting. In addition to our adult TPN and real world evidence studies, our study of DEFENCATH in the pediatric hemodialysis population is on target to begin in the third quarter of this year. Joe TodiscoChief Executive Officer at CorMedix00:08:08And 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 CVC is now live. I would now like to turn the call over to Matt to discuss the company's first quarter financial results and financial position. Matt? Matt DavidExecutive VP & CFO at CorMedix00:08:31Thanks, Joe, and good morning, everyone. Matt DavidExecutive VP & CFO at CorMedix00:08:33I am Matt DavidExecutive VP & CFO at CorMedix00:08:34pleased to be here today to provide an overview of our first quarter twenty twenty five 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 03/31/2025. 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 twenty twenty five financial results, our net revenue for the first quarter of twenty twenty five amounted to $39,100,000 CorMedix achieved profitability for the first quarter as our net income was $20,600,000 or $0.32 per share compared with a net loss of $14,500,000 or $0.25 per share in the first quarter of twenty twenty four. The net income recognized in 2025 was driven by the gross profits associated with the net sales of DefenCap. Matt DavidExecutive VP & CFO at CorMedix00:09:29Operating expenses in the first quarter of twenty twenty five increased approximately 9% to $17,400,000 compared with $15,900,000 in the first quarter of twenty twenty four. R and D expense increased by approximately 281% to $3,200,000 from approximately $800,000 in the first quarter of twenty twenty four, driven by the increase in personnel and clinical trial services in support of our ongoing clinical programs. Selling and marketing expense decreased 29% to $4,500,000 in the first quarter of twenty twenty five compared with $6,300,000 in the first quarter of twenty twenty four. G and A expense increased 11% to $9,700,000 in the first quarter of twenty twenty five versus $8,700,000 in the first quarter of twenty twenty four. 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. Matt DavidExecutive VP & CFO at CorMedix00:10:33We expect those costs to be normalized for the second quarter. The increase in G and 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 twenty twenty five of 19,700,000.0 compared with net cash used in operations of $17,300,000 in the first quarter of twenty twenty four. The increase is driven by our net income for the period versus a net loss in the comparison period. The company has cash and cash equivalents of $77,500,000 as of 03/31/2025. Matt DavidExecutive VP & CFO at CorMedix00:11:12As described previously, we are guiding to 2025 cash operating expenses of approximately $72,000,000 to 78,000,000 The increase over 2024 spending levels is expected to be largely driven by an increase in R and D spending on our clinical initiatives. I will now turn the call back over to Joe for closing remarks. Joe? Joe TodiscoChief Executive Officer at CorMedix00:11:33Thanks, Matt. CorMedix is working diligently on all fronts to increase our existing customer base as well as expanding its DEFENCATH to new therapeutic indications. I appreciate everyone's continued support in CorMedix and I'm happy to take questions. Operator00:11:49We will now begin the question and answer session. Our first question comes from Gregory Renza from RBC Capital. Please go ahead. Gregory RenzaSenior Biotechnology Analyst at RBC Capital Markets00:12:25Great. 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 progress. Gregory RenzaSenior Biotechnology Analyst at RBC Capital Markets00:12:38Just curious if you could just provide how that has how your perceptions and your engagement there has evolved since we've last spoken in 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. I know that's longer term, but just want to see how you're driving to support those goals. Joe TodiscoChief Executive Officer at CorMedix00:13:04No. Thanks, Greg. And with regard to the size of the population, I'm not to speak for 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 quite quickly should we need 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, right to initiate utilization. Joe TodiscoChief Executive Officer at CorMedix00:13:40Certainly nothing is ever set in stone, right with customers and we're waiting for an implementation date. But as I said, we're optimistic or cautiously optimistic as you want to take it. And we're ready to go as soon as they hopefully pull the trigger on a purchase order. Gregory RenzaSenior Biotechnology Analyst at RBC Capital Markets00:14:00Got it. And just maybe just on inventory control, obviously, this is the 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 selling into it and providing DefendCat to the Yes. Joe TodiscoChief Executive Officer at CorMedix00:14:37No, thanks, Greg. The macro level issues right now that are kind of going on, call it 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 largely caused by 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 encouraged investors to look at the first half of the year kind of as a lump sum period. From an inventory prep standpoint, we've got a significant amount of active pharmaceutical ingredient on hand for both heparin and tiraldine that should or will cover not only our current demand run rate for more than a year, but also a good amount of scale up should we need support any increased customer demand. Joe TodiscoChief Executive Officer at CorMedix00:15:36We'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. Gregory RenzaSenior Biotechnology Analyst at RBC Capital Markets00:16:00Got it. It makes sense. Congrats again. I'll hop back into the queue. Joe TodiscoChief Executive Officer at CorMedix00:16:04Thanks, Craig. Operator00:16:06Thank you. Your next question comes from Ruana Ruiz from Leerink Partners. Please go ahead. Roanna RuizSenior Managing Director, Biotechnology Analyst at Leerink Partners00:16:14Hey, morning everyone. So a couple from me. 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. Roanna RuizSenior Managing Director, Biotechnology Analyst at Leerink Partners00:16:29Renal 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? Joe TodiscoChief Executive Officer at CorMedix00:16:41Thanks, Rona. Look, I think we have a number in the queue exactly what percentage our customers or our top customer accounts for. I do believe that U. S. Renal in the first quarter was still more than 80% of shipments. Joe TodiscoChief Executive Officer at CorMedix00:16:59So obviously, is a large driver. They're currently our biggest anchor customer. But we did see good growth in the first quarter, as I said, with smaller customers, with hospitals. On 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. Joe TodiscoChief Executive Officer at CorMedix00:17:24When 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 U. S. 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 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. Roanna RuizSenior Managing Director, Biotechnology Analyst at Leerink Partners00:18:01Got it. And one last follow-up for me. 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 etcetera? Joe TodiscoChief Executive Officer at CorMedix00:18:20Yes. 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. Essentially are all of the same things that we provided to other customers, right, as we've ramped up toward implementation. So as I get more information, I'm certainly going update investors. Joe TodiscoChief Executive Officer at CorMedix00:18:48But right now, as I said, I'm comfortable and we're optimistic that we're on the timelines that we've communicated previously. Roanna RuizSenior Managing Director, Biotechnology Analyst at Leerink Partners00:18:59Got it. Thank you. Operator00:19:02Thank you. Your next question comes from Les Soulevskiy from Truist Securities. Please go ahead. Les SulewskiVP - Biotech Equity Research at Truist Securities00:19:12Good morning. Thank you for taking my questions and congrats on the progress guys. So Joe, perhaps maybe you can talk about U. S. Renal, start there. Les SulewskiVP - Biotech Equity Research at Truist Securities00:19:22You expect the order rates to normalize. I guess maybe can you provide a sense of what patient pool or percent of their patient pool is on DEFENCAF? Are there additional cohorts that could be further implemented? And then in regards to other customers, have they notified you on when they start they will start taking in shipments? And then just kind of your ability to foresee the utilization tracking. Les SulewskiVP - Biotech Equity Research at Truist Securities00:19:46I know you kind of shared some insights into customers providing you some of that, but, are you able to kind of differentiate what's utilization versus inventory buildup? And then I have a follow-up as well on reimbursement. Joe TodiscoChief Executive Officer at CorMedix00:19:59All right. Thanks, Les. I'm going try and go through these. So when we talk about U. S. Joe TodiscoChief Executive Officer at CorMedix00:20:06Renal Care and kind of order rates normalizing, 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 more a little bit more than 80% 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. So So I'd say with the other kind of midsized customers, there's a little bit more runway, I'd say, for growth. Joe TodiscoChief Executive Officer at CorMedix00:20:43We've obviously implemented more recently, right? So we're still kind of in the ramping phase, I think, with both IRC and DCI as well as with a number of the smaller customers. On utilization tracking, 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 first quarter. Joe TodiscoChief Executive Officer at CorMedix00:21:11We do have pretty good visibility as to what is utilization versus what is inventory. And that's the basis for which we've amended our guidance and now we're guiding toward the upper end of our range. Les SulewskiVP - Biotech Equity Research at Truist Securities00:21:26Got it. Very helpful. On the reimbursement front, so now maybe kind of looking ahead, 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? Joe TodiscoChief Executive Officer at CorMedix00:21:52Look, think we're our expectation is to enter into negotiations with EMA plans while TDAPA is still in force, right? And whether that ends up impacting reimbursement in year three or year four, we don't know yet. I don't know that there's a lot of precedent for TDAPA launches entering into direct contracts with MA plans. So that's something we're looking to engage in. Obviously, real world evidence study is a big piece of the data that we're hoping to utilize for those negotiations. Joe TodiscoChief Executive Officer at CorMedix00:22:24What I could say now that's certainly promising when we look at our claims data, about 40% of our claims are currently MA plans, a large number of plans currently providing reimbursement. That's from our view all positive. Les SulewskiVP - Biotech Equity Research at Truist Securities00:22:43Great. And just maybe last one on that front of 40%. What would you expect that to grow to or change to by the end of your TDAPA coverage? Joe TodiscoChief Executive Officer at CorMedix00:22:53Thank Joe TodiscoChief Executive Officer at CorMedix00:22:53you. Well, I wouldn't expect it to grow past fifty-fifty, right, because MA is about fifty percent 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. Joe TodiscoChief Executive Officer at CorMedix00:23:09So that's why I said, I think it's pretty positive that about forty percent of our claims are Medicare Advantage and that's combined with a little bit of commercial and probably some Medicaid as well. Les SulewskiVP - Biotech Equity Research at Truist Securities00:23:20Got it. Okay. That's helpful. Thank you. Operator00:23:26Perfect. Thank you. Our next question comes from Serge Belanger from Needham and Company. Please go ahead. Serge BelangerSenior Analyst at Needham & Company00:23:44Hi, good morning. Joe, I guess a couple of 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 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 Serge BelangerSenior Analyst at Needham & Company00:24:17point? Thanks. Joe TodiscoChief Executive Officer at CorMedix00:24:19Thanks, Sergio. I'll take the first question first. Yes, 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 and T committee, through P and T committee, right? Joe TodiscoChief Executive Officer at CorMedix00:24:34Build champions within these institutions. A lot of them 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. Joe TodiscoChief Executive Officer at CorMedix00:24:55So we're we do think we've got good runway there and an opportunity to grow the business. What it could grow to as a percentage of our business is kind of hard to pin down. Overall, if you look at in terms of the total market opportunity, the TAM about 10% of the unit volume flows through inpatient. As we said in the past, think there's a little bit more durable pricing perhaps on the inpatient side that could lead to a higher dollar value. And I had mentioned that we essentially for April, we kind of doubled our rate of shipments, right, from it was 3% of our shipments in the first quarter, inpatients about 6% so far leading into in the second quarter. Joe TodiscoChief Executive Officer at CorMedix00:25:45As 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 a number of what we expect it to be. It really depends on a lot of variables. Joe TodiscoChief Executive Officer at CorMedix00:26:15Just 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. Of the things that we're keeping an eye on in July, 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 TDAPA. Joe TodiscoChief Executive Officer at CorMedix00:26:46We'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. Legislation is always an uphill fight certainly in this Congress. But there is a lot of, I'd say, momentum amongst stakeholders that want to see changes to DAPA to make it either longer in duration, more sustainable over time and perhaps better drive utilization of innovative therapies. Serge BelangerSenior Analyst at Needham & Company00:27:31Thanks. Operator00:27:34Thank you. Now I'll turn the conference over to Dan Ferry for written questions from the audience. Dan FerryManaging Director at LifeSci Advisors, LLC00:27:42Thank you, operator. Joe, we do have one written question from the audience here. Can you provide any feedback from providers or customers on their experience with DefendCast to date? Joe TodiscoChief Executive Officer at CorMedix00:28:01Okay. That's a good question, Dan. 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. Liz HurlburtEVP, Chief Clinical Strategy and Operations Officer at CorMedix00:28:11Sure. 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, The clinicians overall have been pretty quick to adopt and introduce patients. I also think our reimbursement support services with Perspectus have been instrumental in supporting customers with the nuances of TDAPA and NTAP claims, taking that unknown factor out of the aspect. Liz HurlburtEVP, Chief Clinical Strategy and Operations Officer at CorMedix00:28:48Overall, it's been really positive. Dan FerryManaging Director at LifeSci Advisors, LLC00:28:54Thanks Liz. Joe TodiscoChief Executive Officer at CorMedix00:28:54Thanks Liz. Dan FerryManaging Director at LifeSci Advisors, LLC00:28:59Joe, with that said, I don't have any other further questions from the audience. That said, operator, you may close the call. Operator00:29:12Perfect. Thank you. Joe TodiscoChief Executive Officer at CorMedix00:29:13All right. Joe TodiscoChief Executive Officer at CorMedix00:29:13Well, thank everybody. Operator00:29:17The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read moreParticipantsExecutivesJoe TodiscoChief Executive OfficerMatt DavidExecutive VP & CFOLiz HurlburtEVP, Chief Clinical Strategy and Operations OfficerAnalystsDan FerryManaging Director at LifeSci Advisors, LLCGregory RenzaSenior Biotechnology Analyst at RBC Capital MarketsRoanna RuizSenior Managing Director, Biotechnology Analyst at Leerink PartnersLes SulewskiVP - Biotech Equity Research at Truist SecuritiesSerge BelangerSenior Analyst at Needham & CompanyPowered by