Good day, and welcome to the CorMedix Third Quarter 2025 Earnings and Corporate Update Conference Call. Please note this event is being recorded. I would now like to turn the conference over to Daniel Ferry of LifeSci Advisors. Please go ahead.

Thank you, operator. Good morning, and welcome to the CorMedix Third Quarter 2025 Earnings and Corporate Update Conference Call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix; and he is joined by Liz Hurlburt, EVP and Chief Operating Officer; and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnick Kaufman, EVP and Chief Legal and Compliance Officer; and Dr. Matt David, EVP and Chief Business Officer, are on the line and will be available during the Q&A session. Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are statements other than statements of historical fact regarding management's expectations, beliefs, goals and plans about the company's prospects and future financial position. Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risks and uncertainties described in greater detail in CorMedix 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. 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 8-K filed with the SEC. This information is available on the Investor Relations section of CorMedix website. At this time, it's now my pleasure to turn the call over to Joe Todisco, Chief Executive Officer of CorMedix. Joe, please go ahead.

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. This has been an exciting quarter in the evolution of CorMedix as we announced and closed the acquisition of Melinta Therapeutics in a combination of cash and stock transaction. This deal is transformational for CorMedix, creating a diversified specialty pharmaceutical company with a broad portfolio of commercial and late-stage pipeline products. Integration of the legacy CorMedix and Melinta operations has progressed faster than originally expected. As we announced in October, we expect to capture approximately $30 million of the projected $35 million to $45 million of total synergies on a run rate basis before the end of 2025. I'm excited to announce today that as part of our integration, CorMedix, Inc. will be rebranding as CorMedix Therapeutics, and all employees will unify under this company name. We're also adopting a new logo to signify the go-forward organizational commitment to develop and commercialize novel therapies for the prevention and treatment of life-threatening conditions. This past quarter marks the most successful quarter from a financial perspective in company history, registering record levels for revenue of $104.3 million, net income of $108.6 million, and adjusted EBITDA of $71.8 million. Our revenue performance was largely driven by faster-than-expected adoption by our DefenCath LDO customer, utilization growth from our existing customer base, and partial quarter contribution from the Melinta portfolio assets. Based on the recent momentum, today, we are raising our pro forma combined full year revenue guidance from a minimum of $375 million to a range of $390 million to $410 million. In addition, we are increasing our previous guidance for pro forma fully synergized adjusted EBITDA for 2025 from a range of $165 million to $185 million to a new range of $220 million to $240 million. On the business development front, we also successfully closed our strategic minority investment in Talphera Inc. This small strategic investment gives us a foothold in a late-stage critical care product that is highly complementary to CorMedix' acute care portfolio. As part of the transaction, CorMedix has granted a right-of-first negotiation to acquire Talphera following the announcement of Phase III results, which we anticipate to be available in the first half of 2026. We will continue to evaluate Talphera in the coming months as their clinical trial progresses toward completion. With respect to DefenCath, we are very pleased overall with the utilization of DefenCath in the outpatient hemodialysis segment during our initial phase of TDAPA, and we have now begun planning with customers for the post-TDAPA add-on periods, which we expect will begin in July of 2026. In line with our strategy to increase patient utilization of DefenCath during our post-TDAPA add-on periods, we'll be working over the coming months to finalize supply pricing with customers under existing contracts based upon the final post-TDAPA add-on framework, as well as engaging in conversations with Medicare Advantage payers following the publication of our real-world evidence data later this year. Lastly, as CorMedix evolves, I think it's important for investors to begin focusing on important near- and medium-term catalysts and value drivers for the company beyond the hemodialysis sector. First and most importantly, the second quarter of 2026 is expected to bring top line data for the use of Rezzayo as prophylaxis of invasive fungal infections. We believe the total addressable market for immune compromised patients undergoing antifungal prophylaxis is more than $2 billion. The Phase III ReSPECT study is running head-to-head against the current standard of care, which is a combination of posaconazole, an antifungal, and Bactrim, an antibiotic that also has antifungal activity. Posaconazole demonstrates severe drug-to-drug interactions with many medications the target patient population is currently taking, including immunosuppressive drugs like tacrolimus and cyclosporine, as well as numerous therapeutics used in treating hematological malignancies such as leukemia, multiple myeloma or non-Hodgkin's lymphoma, all patient populations that may undergo bone and marrow transplantation as part of their therapy. For these patients, Rezzayo used as prophylaxis against these invasive fungal infections could represent a new standard of care that may allow patients to experience less drug-to-drug interactions, less frequent dosing, and more flexibility in their setting of care for treatment. Our second near-term catalyst outside of hemodialysis is the expected expansion of DefenCath into the prevention of CLABSI for adult patients receiving total parenteral nutrition or TPN. Our most recent market research continues to highlight the critical unmet medical need and pervasively high bloodstream infection rates in this patient population. Prophylactic intervention is urgently needed for these vulnerable patients. We have previously guided to a total addressable market in this indication of up to $750 million and anticipate Phase III completion as early as the end of 2026 or beginning of 2027. I believe that CorMedix has done an exceptional job of maximizing the value of the initial TDAPA period afforded to DefenCath as a long-term strategy in hemodialysis for post-TDAPA periods and has redeployed cash flow into a pipeline that can position the company for long-term sustainable growth. I am excited about the future. I would now like to turn the call over to our Chief Operating Officer, Liz Hurlburt, to provide an update on clinical activities, operations, and integration. Liz, please go ahead.

Thank you, Joe, and good morning. The combined clinical development and operation teams, along with field medical affairs have been working diligently on numerous clinical activities. As we shared in late September, enrollment for the global Phase III ReSPECT study evaluating Rezzayo for the prophylaxis of fungal infections in allogeneic bone marrow transplant patients has completed. This pivotal trial is being conducted by our global partner, Mundipharma, and the team has begun to progress the program in anticipation of study closeout. The team continues to work closely with investigators and clinical experts in the field to deepen our understanding of the evolving clinical practices and needs of these patients. We expect to announce top line results from the ReSPECT study in the second quarter of 2026. Turning to DefenCath. I'm pleased to share that the Phase III Nutri-Guard clinical study, which evaluates the reduction in central-line associated bloodstream infections or CLABSI for adult patients receiving total parental nutrition via a central venous catheter has garnered international interest. In the coming months, we will expand clinical study sites into Turkey to broaden the diversity of patients and potentially expedite enrollment timelines. At this time, we are still anticipating study completion by the end of 2026 or early 2027. Lastly, our real-world evidence study in collaboration with U.S. Renal Care has entered the second year of data collection. The team is currently conducting an analysis of the first year of data, and we anticipate sharing those interim results by the end of this year. This study is designed to demonstrate the real-world effects of the broad use of DefenCath in a real-world setting and examines not only the reduction in catheter-related bloodstream infections or CRBSI, but also reduction in costly infection-related hospitalizations. Secondary data points of missed treatment sessions, antibiotic utilization, and TPA utilization are also being reviewed. Now turning to integration progress. I am heartened by the significant efforts of the teams to both integrate and optimize operations as a unified organization. We have made meaningful strides in merging the teams, identifying synergies, and creatively preserving key elements of both legacy organizations. In addition to our new corporate branding as CorMedix Therapeutics, we have refined our mission, vision, and values as a new organization and are excited to see our integrated teams work together to create a new culture and execute key objectives. Currently, all functional areas have fully integrated from a personnel standpoint, which includes clinical, medical affairs, technical operations, supply chain, finance, legal, quality, human resources, and commercial. Systems integration is still underway and expected to complete in 2026 in line with our original estimates. The legacy contracted hospital sales team for DefenCath will conclude its service by the end of this year, and DefenCath promotion in the hospital setting will transition in January to the post-integration internal field organization. Beginning in early Q1 2026, our unified sales organization covering acute care clinics and hospitals will seamlessly support all promoted portfolio products, including both DefenCath and Rezzayo and will offer enhanced capabilities and customer support. The collective expertise of our team positions us to deliver comprehensive solutions to many challenges in the acute care space and ultimately with the goal of driving better patient outcomes. We are incredibly proud of the team and their hard work in moving this integration forward while continuing to focus on sales and patient access. I would now like to turn the call over to Susan to discuss the company's third quarter financial results and financial position. Susan?

Thanks, Liz, and good morning, everyone. We are pleased to report our third quarter financial results, reflecting continued commercial momentum and a path towards sustained profitability. Our results demonstrate solid growth across the business, including strong performance from DefenCath and growth in the legacy Melinta product portfolio. We closed the Melinta acquisition on August 29, 2025, and therefore, 1 month of its operations are included in our consolidated financial results for the third quarter. The company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2025. I encourage you to read the information contained in the report for a more complete discussion of our financial results. As Joe mentioned, for the third quarter, net revenue was $104.3 million, including the DefenCath sales of $88.8 million, representing a total net revenue increase of $77.5 million year-over-year. The remainder of revenue totaling approximately $15.5 million reflects the contribution from Melinta for the month of September, $12.8 million of which was driven by Melinta portfolio sales. Operating expenses for the third quarter were $42.6 million compared to $14.1 million for CorMedix on a stand-alone basis in the same quarter last year. The increase of $28.5 million over the prior period includes nonrecurring costs of $12.7 million associated with the transaction and integration as well as severance costs associated with the Melinta acquisition. Other increases in costs were driven by stock-based compensation, OpEx contribution from Melinta's business and increased investment in R&D associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI and TPN patients. While costs have increased in these areas this past quarter, they are aligned with our previously communicated expectations and support our strategic priority, which is to position the company for long-term sustainable growth. In addition, as Joe mentioned, we are working to quickly capture synergies associated with the Melinta acquisition with approximately $30 million of synergies on a run rate basis expected to be captured from actions taken prior to the end of the year. We expect to realize these synergies in the P&L beginning in the fourth quarter of 2025. Overall, for the third quarter of 2025, we achieved net income of $108.6 million or $1.26 per diluted share marking meaningful progress compared to the third quarter of 2024, during which period we recognized a loss of $2.8 million and a net loss per diluted share of $0.05. A large driver of net income for the quarter was a substantial tax benefit of $59.7 million due primarily to the realization of deferred tax assets, equating to 100% of the CorMedix' historical net operating losses or NOLs. The recognition of this sizable tax benefit underscores our confidence in sustained future profitability, which will drive the utilization of our NOL carryforwards against taxable income, which equates to cash tax savings and tangible value for the company and for shareholders. Turning to non-GAAP measures. Adjusted EBITDA for the third quarter of 2025 was $71.8 million, up from a loss of $2 million in the third quarter of 2024, reflecting the momentum of our operations over the past year. This non-GAAP measure provides additional insight into our core operating performance and profitability trends, highlights the underlying strength of our operations, and excludes onetime acquisition-related costs, stock-based compensation, and the tax benefit we realized this quarter. Please refer to our press release that we issued this morning for a reconciliation of this non-GAAP measure to GAAP net income. On the cash front, we raised gross proceeds of $150 million in a convertible debt offering, and those proceeds together with cash on hand and $40 million in common stock issued to the seller were used to fund the acquisition of Melinta in August 2025. This financing strategy supported the transaction while maintaining what we believe to be a healthy liquidity position and flexibility for future growth investments. As a result, our cash flow during the third quarter reflects the timing of these financing and acquisition activities, and we ended the quarter with cash, cash equivalents, and short-term investments of $55.7 million. Looking ahead, we expect significant cash generation in the fourth quarter, driven by strong operational performance. We anticipate ending the year with approximately $100 million of cash and cash equivalents, supported by ongoing positive operating cash flow and working capital optimization. To drive this balance, we are guiding to fourth quarter net revenue in the range of $115 million to $135 million, reflecting continued momentum from DefenCath and a full quarter contribution from Melinta. And now I will turn the call back to Joe for closing remarks. Joe?

Thank you, Susan. The third quarter of 2025 marked a period of meaningful progress and disciplined execution. We advanced our strategic objectives, strengthened our financial foundation, and delivered solid results while completing a transformative acquisition. The company now has a diversified product portfolio, multiple late-stage pipeline opportunities, financial flexibility, and a diversified capital structure to support future growth. We remain confident in the outlook for the remainder of this year and the path to sustained growth and profitability. I'd now like the operator to open up for questions.

Our first question comes from Les Sulewski with Truist.

Congrats on the progress. First, on DefenCath, do you have a sense of inventory stocking versus utilization in 3Q, and we understand you're not providing guidance for next year at this time. But how should we think about potential seasonality throughout the year? Or how ordering rates could impact quarterly revenue cadence? And then outside of additional cohort expansion, is 4Q implied guidance, I guess, a good representation of normalized utilization patterns? And then I have a follow-up.

Thank you, Les. I'll do my best to address these questions. Regarding third quarter inventory levels, it seems our smaller customers are maintaining stock for about 2 to 3 weeks on average. The LDO is holding around 3 to 4 weeks, which appears to be consistent with what we've observed normally. There was likely a few million dollars shipped around the transition that you might be looking at when comparing third quarter and fourth quarter DefenCath revenue trends. A couple of million dollars were recorded right at that transition point, which affected the third quarter that would have otherwise been counted in the fourth quarter. Overall, I wouldn't say there's a significant increase in stocking for the third quarter; it aligns with regular inventory that they keep on hand. The second question seemed to touch on quarter-to-quarter guidance and seasonality. When we separate the DefenCath business from Melinta, we don't observe historical seasonality based on the time of year when patients undergo hemodialysis. Over the past two years, we've grown our customer base and cohorts, and we've seen increased utilization and overall revenue growth. People are indeed looking ahead to next year, but I'm unsure when we will be prepared to provide financial guidance for 2026. It's important to note, especially with the changes coming in July due to TDAPA, there may be a slight upfront effect on overall revenue, though not necessarily on utilization for the entire year. We are still assessing how the full year will unfold. In the Melinta portfolio, while many products are anti-infectives, they do not fall under the cough and cold category, so we don't expect to see the same kind of winter seasonality. There typically is a small amount of stocking in December that carries into January across all products, but we do not anticipate significant seasonality impacting the business either. Regarding cohort expansion, I believe there are still growth opportunities with all our customers, particularly with DefenCath. We are concentrating on this area in the upcoming months, especially after TDAPA. A significant portion of our strategy following TDAPA involves engaging with Medicare Advantage. We currently think that most patients using DefenCath in outpatient settings are under Medicare fee-for-service. However, Medicare Advantage has now become the largest group of patients and represents a key opportunity for our future growth post-TDAPA. Did you have a follow-up, Les?

I do. It is on TDAPA actually. So is the real-world evidence that mutually inclusive with agreements on final pricing around the post-TDAPA period? Can you provide maybe some sort of a sense of your inklings into the price negotiation period heading into July on the TDAPA side?

Well, look, you have to separate, the real-world evidence in our view is going to be most applicable and useful with Medicare Advantage, right? Medicare Advantage is not bound by the post-TDAPA add-on. They have the flexibility to contract separately, right? That's the strategy we want to employ. We have very little market share right now of Medicare Advantage patients, and we think it's a compelling value proposition for the MA plan. Ultimately, they are the payer of those downstream costs, those hospitalizations that drive so much cost in the healthcare system. So we want to, obviously, with data, make the argument that investing in prevention, right, is going to save them a significant amount of value. On the traditional Medicare side, there's not much of an opportunity for negotiation, Les. It's really based on when the ESRD final rule publishes, what they ultimately determine is going to be the fee-for-service adjustment, and we'll work around that once it's published.

And the next question comes from Jason Butler with Citizens.

Congrats on the quarter. Two for me, Joe. First one, you mentioned that the ordering from the LDO has been faster than you'd expected. How has the use been in terms of the number of patients and the type of patients that the LDO has been using the product in? And then secondly, when we think about the real-world data coming at the end of the year, can you just give us some color about what to expect in terms of the number of patients, the endpoints, and how we assess the benefit here relative, for example, to the Phase III results, if that is at all relevant?

Thank you, Jason. Regarding the LDO, it’s not just about faster orders. The inventory data shows that the utilization is also occurring more rapidly than we expected during the ramp-up. We initially targeted a rollout of 6,000 patients, but we currently believe we are significantly exceeding that number, although we can't provide an exact figure at this moment. We're pleased with the rollout so far. As for stratification, I’m not sure if you meant high risk or insurance type. We don't have clear visibility into that data, but we believe it primarily consists of fee-for-service patients currently, with a potential for Medicare Advantage. I'll have Liz address the question about real-world evidence.

Sure. Jason, so we are expecting the year 1 results to come out later this year. It's approximately 2,000 patients. So we're double what we had in our Phase III LOCK-IT study. And we expect that we're going to read out data on the reduction in actual CRBSI, reduction in hospitalizations due to CRBSI. There are some secondary endpoints we're looking at as well, missed treatment sessions, utilization of TPA, and antibiotic utilization. And those are all being compared to the historic infection rates. So we should have that out sometime in the next 6 to 7 weeks.

And the next question comes from Roanna Ruiz with Leerink Partners.

So a couple from me. First one is, given some of the trends you're seeing in DefenCath utilization so far, how should we think about the second half of '26 revenues and pricing dynamics post TDAPA? And what are some of the pushes and pulls that could drive DefenCath revenues either higher or lower after this TDAPA period?

Thanks, Roanna. As I think I said to Les, we're not in a position to give a lot of clarity right now on that back part of '26. Obviously, we do know there's going to be price compression, right, because it's going to shift from the ASP method into the post-TDAPA add-on absent the passing of legislation that is currently pending before the Senate. But the pushes and pulls would be related to how CMS does the calculation for utilization. The method that they had proposed in the proposed rule, which we commented on, would have created or will create a dynamic where the adjustment for Q3 and 4 of '26 is lower than the adjustment for '27. And if that's the framework, I think we're prepared to work around that. We're just waiting for a final determination in the final rule, which was expected a couple of weeks ago. I know the government shutdown has delayed quite a few things. We're expecting it to come any day now. And once we have that, we'll be able to finalize things with customers and just continue moving forward.

Got it. That's helpful. And another quick follow-up for me. I was curious, with your discussions with customers into the post-TDAPA period, what are some of the goals of these discussions? And what data are you bringing forward right now to help those discussions as well?

I believe that real-world evidence data will be essential, and we expect to have the interim midpoint data available by the end of the year. Demonstrating the impact on the healthcare system is crucial. We've received anecdotal feedback from various customers who have noticed a significant difference in their infection rates. While that's not formal data, their experiences and observations are certainly a positive outcome that we aim to build upon.

And the next question comes from Brandon Folkes with H.C. Wainwright.

Congrats on all the progress. Two from me maybe, just firstly, any color on how you're viewing the DefenCath inpatient opportunity? How is that progressing? And how do you expect that to progress in '26, just given the scale and relationships that Melinta brings in that setting? And then maybe secondly, just changing gears to Niyad. How are you thinking about that investment while in Talphera, but sort of Niyad as a product? It seems like a product you can sort of simply drop into your commercial infrastructure and drive pretty strong EBITDA accretion on day 1. Is that how you think about the product? Or do you think there's material investment required behind that opportunity should you execute on your option?

Thank you, Brandon. On the inpatient side, we've made good progress this year. While it’s a small portion compared to our outpatient gains, we've seen steady growth. As Liz mentioned, starting next year, we'll transition from the legacy contracted inpatient team for CorMedix to a new combined field team following the Melinta integration. We will train that new team in December on DefenCath, and in January, they will start promoting it in the inpatient sector. I expect this to create opportunities for growth. Although inpatient volume is lower, it offers better pricing and higher revenue per patient, making it a good profit opportunity for DefenCath in that setting. Regarding Niyad, we made a strategic investment because we believe in the product and its alignment with our commercial infrastructure. We will continue to monitor the clinical results and assess the opportunity. I am not ready to say that no investment would be needed if we were to acquire the business. There would certainly be some investment if we acquired Talphera, likely including marketing expenses. However, we believe it fits well with our current sales deployment.

And the next question comes from Serge Belanger with Needham & Company.

A couple for us, Joe. The first one, can you just give us an update on the pricing of DefenCath over the third quarter? And then on TDAPA, it sounds like the ESRD rule is going to determine the calculation for the post period starting in July. Are you going to be able to provide guidance once the ESRD rule is published? And then secondly, are you aware of any legislation bills in Congress that could modify the TDAPA reimbursement?

Thanks, Serge. Regarding the pricing of DefenCath, we typically do not disclose specifics. Historically, we've indicated that there is slight erosion on a quarter-over-quarter basis due to our agreements. Our average selling price is set as a discount off governmental ASP, which has trend downwards quarterly, but the volume has significantly increased to compensate for the price changes. The TDAPA rule and methodology will play a crucial role here. We have agreements established with all our customers, with formulas outlining the pricing determination. One of the aspects we are monitoring is whether CMS will use a methodology indicating that the third and fourth quarters of '26 will be lower than in '27. If that happens, we might negotiate a blended price over time. Although I don’t plan to share customer-specific pricing, we should be able to provide more directional insights early next year regarding what we anticipate for the latter part of the year. Furthermore, regarding the legislation, there is a proposed bipartisan bill by Senator Booker and Marsha Blackburn that would introduce significant changes to TDAPA, with a focus on promoting innovation. Notably, it would extend the ASP-based pricing period from 2 years to 3 years and make the post-TDAPA add-on permanent while tracking drug utilization. Currently, CMS bundles based on market share of total dialysis, regardless of drug dispensation. The new proposed methodology would allocate market share based on a percentage of drug claims submitted over time, which I believe is a better approach. I am hopeful that this legislation will progress into law early next year. I understand the government shutdown has delayed several initiatives, but I am optimistic that the new Congress in early '26 can move it forward.

I'll now pass it to Dan Ferry for written questions from the audience.

Thank you, operator. Joe, we had quite a few here, but it looks like a lot of them were covered during the live Q&A. I do have one additional one, though that you might help us out with here. What do you think is misunderstood regarding the Melinta transaction? And why are investors not crediting the value of Melinta?

Thank you, Dan. I found it amusing as I reviewed the analyst questions, noting that we didn't receive a single inquiry about Rezzayo or the potential impact of Melinta. There's been significant historical attention on DefenCath, which is understandable, as it's currently our largest revenue contributor. However, when I consider the reasons for acquiring Melinta and its contributions, I believe there are several aspects that aren't fully recognized. One key point is the stabilizing effect of the acquired base business, which helps mitigate risks. We received many questions about what may occur later this year with DefenCath, but the Melinta business offers a stable revenue base that enables us to leverage operational synergies and solidify our position. Moreover, I feel that the potential for Rezzayo prophylaxis as a pipeline opportunity is not being valued properly. This could surpass even DefenCath in peak sales, with a total addressable market exceeding $2 billion. There is a segment already using prophylactic antifungal therapy for immune-compromised patients, so we don't need to alter existing treatment patterns. This differs from the launch of DefenCath, where we had to change established practices. In this case, prophylactic measures are already in place, but the current standard of care has several shortcomings, including severe drug-drug interactions that should not be overlooked. Switching to weekly dosing could enhance convenience for patients, and much of the administration could take place in outpatient hematology/oncology clinics, which would benefit from buy-and-bill reimbursement models. Therefore, I see considerable potential for Rezzayo prophylaxis as a future growth driver for the business, in addition to TPN. We recently updated our internal market research, which has validated the high infection rates in that patient population and confirmed that doctors are actively seeking interventions. We are genuinely enthusiastic about the future growth opportunities for the business beyond hemodialysis, and I believe those are crucial factors that investors should start paying more attention to.

Excellent. Okay. Thank you, Joe. Operator, you may now close the call.

This concludes our question-and-answer session. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.