CorMedix Inc.CRMDNASDAQ
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Operator: Good morning, and welcome to the CorMedix Inc. Fourth Quarter and Full Year 2025 Earnings and Corporate Update Conference Call. Today's conference call is being recorded. There will be a question and answer session at the end of today's presentation, and instructions on how to ask a question will be given at that time. At this time, I would like to turn the conference call over to Daniel Ferry from LifeSci Advisors. Please go ahead.
Daniel Ferry: Good morning, and welcome to the CorMedix Inc. fourth quarter and full year 2025 Earnings and Corporate Update Conference Call. Leading the call today is Joseph Todisco, Chairman and Chief Executive Officer of CorMedix Inc., and he is joined by Elizabeth Masson-Hurlburt, EVP and Chief Operating Officer, and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnickauffen, EVP and Chief Legal and Compliance Officer, Mike Seckler, EVP and Chief Commercial Officer, and Dr. Matthew T. David, EVP and Chief Business Officer, are also 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 facts regarding management's expectations, beliefs, goals, and plans about the company's prospects and future financial position. Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risks and uncertainties described in greater detail in CorMedix Inc.'s filings with the SEC, which are available free of charge at the SEC's website or upon request from CorMedix Inc. CorMedix Inc. may not actually achieve the goals or plans described in these forward-looking statements. Investors should not place undue reliance on these statements. CorMedix Inc. 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 Inc.'s earnings release and the current report on Form 8-Ks filed with the SEC. This information is also available on the Investor Relations section of CorMedix Inc.'s site. At this time, it is now my pleasure to turn the call over to Joseph Todisco, Chairman and Chief Executive Officer of CorMedix Inc. Joseph, please go ahead.
Joseph Todisco: Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. 2025 was truly a transformational year for CorMedix Inc. While DEFENCATH achieved peak sales of just under $260,000,000, we are excited to have both announced and closed the acquisition of Melinta Therapeutics in the third quarter of the year. In addition, the team worked expeditiously to facilitate integration and achieve our target synergy of $35,000,000 during 2025. This was a monumental achievement and truly a testament to the operational execution capabilities of the CorMedix Inc. leadership team. As we turn our attention to the year ahead, there is much focus on our post TDAPA add-on period strategy for maintaining patient utilization rates for DEFENCATH in outpatient hemodialysis. As a reminder, on July 1, the TDAPA reimbursement for DEFENCATH will transition from a buy-and-bill format to a bundled add-on mechanism. We have had multiple conversations with our top customers and are in the process of finalizing supply pricing for Q3 2026 as well as for 2027. At this time, we are affirming our 2026 DEFENCATH guidance of $150,000,000 to $170,000,000 and 2027 DEFENCATH guidance of $100,000,000 to $125,000,000. With respect to 2026, we expect much of the revenue concentration to be front-loaded in the first half of the year as price erosion related to the post TDAPA add-on occurs in the fourth quarter. Assuming CMS utilizes the same methodology to calculate the 2027 bundle addition, we do expect a meaningful increase in traditional Medicare provider reimbursement in 2027, which we expect to translate into a higher net selling price in 2027 compared to Q3 2026. To that extent, we took the extra step of issuing 2027 DEFENCATH guidance based on existing patient utilization rates as well as our current estimates for the range of net selling prices and it does not include potential upside from new customers or managed care contracting. In addition to DEFENCATH guidance, the company is also affirming full year 2026 financial guidance of revenue of $300,000,000 to $320,000,000 and adjusted EBITDA of $100,000,000 to $125,000,000. That said, we are actively in discussions with multiple Medicare Advantage providers as well as new potential customers for DEFENCATH in both the inpatient and outpatient settings of care, focused on execution of sales and marketing efforts for RIZEAO, Minocin, and Vabomere, and we will evaluate appropriate updates to financial guidance as we progress throughout 2026. This past month, we completed our first analyst R&D Day, which we focused on educating our analysts and investor community on the market opportunity for our antifungal product, RIZEAO, its current approved indication in the treatment of invasive fungal infections, as well as our key pipeline assets of RIZEAO in development for prophylaxis of invasive fungal infections and DEFENCATH in development for prevention of CLABSI in adult patients receiving total parenteral nutrition. Elizabeth will provide an update on the status of these development programs shortly. During the Analyst Day event, stakeholders were given the opportunity to engage with multiple panels of physician thought leaders around key aspects for each of these three growth opportunities for CorMedix Inc. The webcast of the event and associated materials remains available on our website and I encourage all investors to review those materials. The feedback from thought leaders was excellent and underscores our view for the large potential market opportunity for RIZEAO, which we estimate at approximately $2,500,000,000 across both potential indications, and for DEFENCATH in TPN, which we estimate between $500,000,000 and $750,000,000. 2026 is expected to be a transitional year for CorMedix Inc., with a heightened investor focus on new catalysts and value drivers, most notably our Phase III RESPECT data for RIZEAO in prophylaxis which is on track for the second quarter of this year. With the acquisition of Melinta, not only did we acquire what we believe will be an exceptional growth asset in RIZEAO, but also added highly durable institutionally administered products like Minocin and Vabomere, which we expect to provide a stable base of revenue while the company builds toward future growth. I believe CorMedix Inc. has done an exceptional job of maximizing the value of the initial TDAPA period afforded to DEFENCATH in outpatient hemodialysis and parlayed that success into building a pipeline that positions the company for long-term sustainable growth. I would now like to turn the call over to our Chief Operating Officer, Elizabeth Masson-Hurlburt, to provide an update on clinical activities. Elizabeth? Please go ahead.
Elizabeth Masson-Hurlburt: Thank you, Joseph, and good morning. The combined clinical development and operations teams, along with field medical affairs, have been working diligently on numerous clinical activities. As we shared last fall, enrollment for the global Phase III RESPECT study evaluating RIZEAO for the prophylaxis of fungal infection in adult allogeneic bone marrow transplant patients completed in September. This pivotal trial is being conducted by our global partner, Mundipharma, who has confirmed that all sites have completed study participation and they are on track for an anticipated database lock later this month. We expect to announce top-line data from the RESPECT study in 2026. Top-line results will include the primary efficacy outcome of fungal-free survival at day 90, discontinuation of study drug due to toxicity or intolerance, all-cause mortality and attributable mortality with invasive fungal disease as determined by the Data Review Committee, and the cumulative incidence of invasive fungal disease at day 90 by the Data Review Committee and by azole choice. Additionally, safety data, overall adverse events, treatment-emergent adverse events, and serious adverse events are expected to be included in top-line results. The team continues to work closely with investigators and clinical experts in the field to deepen our understanding of the evolving clinical practices and the needs of these patients as we prepare to support a potential commercialization in 2027. As Joseph mentioned earlier, our panel of thought leaders provided excellent insights into the market opportunity for a long-acting echinocandin in the prophylaxis of invasive fungal infections and we are looking forward to our Phase III data readout. Turning to DEFENCATH, I am pleased to share that the Phase III NEUTROGUARD clinical study, which is evaluating the impact on central line-associated bloodstream infections, or CLABSI, in adult patients receiving total parenteral nutrition via a central venous catheter, is approximately 30% enrolled toward our minimum patient target of 90 patients. We are working to increase enrollment rates as we progress throughout 2026 with new sites in Turkey. At this time, we are still anticipating study completion in early 2027. The adaptive design is 90 minimum and a maximum of 200 participants based on the incidence rate of CLABSI. An interim assessment will be made by the independent data monitoring committee after 15 participants have experienced a CLABSI event. I would now like to turn the call over to Susan to discuss the company's fourth quarter and full year financial results and financial position. Susan?
Susan Blum: Thanks, Elizabeth, and good morning, everyone. We are pleased to share our fourth quarter and full year 2025 financial results, which reflect our ongoing commercial and operational execution. A few things to note on the financial results before I jump in. Following the close of the Melinta acquisition on 08/29/2025, 2025 represents the first full reporting period incorporating Melinta's operations into our consolidated results. Also, the company has filed its annual report on Form 10-K for the year ended 12/31/2025, and I encourage you to review this filing for a more comprehensive discussion of our financial performance and operating results. As Joseph mentioned, we had a strong quarter on the revenue front. For the fourth quarter, revenue of $128.6 million reflected continued growth across our commercial portfolio, driven primarily by DEFENCATH, which contributed $91.2 million, and supplemented by a full-quarter contribution from the Melinta portfolio, which totaled $37.4 million, compared to net revenue of $31.312 million in 2024 which included only results from DEFENCATH. This represents a meaningful year-over-year increase and highlights the company's ability to execute on product launches and business development initiatives. Total revenue on a pro forma basis for 2025, which is full year revenue for both the CorMedix Inc. and Melinta businesses, was $401.3 million, which is in line with our previously established guidance. Of the total, DEFENCATH generated $258.8 million in net sales for the year. Turning to OpEx, fourth quarter operating expenses of $48.2 million increased from $17.1 million in the comparable prior-year period, reflecting the expected expanded cost structure of the combined organization, merger-related costs associated with the Melinta acquisition including severance expenses, and additional investment in expanded indications for DEFENCATH, most notably our Phase III clinical program focused on the prevention of CLABSI in TPN patients. Our operating expenses for the fourth quarter were consistent with our expectations and aligned with our strategic focus on building a platform for long-term sustainable growth, which was supported by the execution and integration of the Melinta acquisition. Our employee base has grown significantly in connection with the merger and scaling of the business. Last year at this time, we had a workforce of approximately 100 people and today have just under 200 employees. The expanded infrastructure serves to support growth and is expected to provide significant operating leverage in the periods to come. Now that we have successfully streamlined the two organizations, we can focus on executing our business growth strategy in preparation for the anticipated new launch opportunities of DEFENCATH in TPN and RIZEAO for prophylaxis. On the bottom line, CorMedix Inc. recognized net income of $14.0 million in 2025. Net income was impacted by tax expense of $42.4 million, the majority of which was non-cash, resulting from the utilization of deferred tax assets that were established in 2025. On a pre-tax basis for the fourth quarter, income was $56.4 million, an increase of $43.0 million from 2024. Turning to non-GAAP results, adjusted EBITDA for the fourth quarter was $77.2 million, which was within our previously established guidance and reflects modest growth quarter over quarter. This metric excludes one-time acquisition-related and reorganization costs, stock-based compensation, and the tax benefit and expenses recognized during the year, and it provides additional insight into the strength of our core operating performance. A reconciliation to GAAP results is included in the press release issued with our earnings announcement. From a liquidity perspective, we ended the quarter with cash and cash equivalents and short-term investments of $148.5 million, driven by strong operating cash flow of almost $100 million during the quarter and ongoing working capital optimization. Where we stand today, given our financial flexibility and commercial momentum, we believe we are well positioned for both organic growth from existing pipeline and promoted assets and potential inorganic growth from new business development opportunities. I am excited to be a part of the journey as we move forward. And now I will turn the call back to Joseph for closing remarks.
Joseph Todisco: As I mentioned, 2025 was a transformational year. 2026 will be a transitional year that we believe sets up CorMedix Inc. for long-term sustainable growth in 2027 and beyond. We recently announced the share repurchase program and have been repurchasing shares throughout the first quarter. We intend to continue to be active throughout the year, subject to normal blackout periods, applicable volume restrictions, and other business needs, as we believe our balance sheet has sufficient flexibility to pursue this repurchase while leaving sufficient dry powder for new business development opportunities. The company sits here today with a diversified product portfolio, multiple late-stage pipeline opportunities, financial flexibility, and a capital structure to support future growth. We remain confident in the outlook for this year, our path to future growth, and sustained profitability. I would like to now open up the call for Q&A.
Operator: We will now begin the question and answer session. The first question today comes from Roanna Clarissa Ruiz with Leerink. Please go ahead.
Roanna Clarissa Ruiz: Hey, good morning everyone. A couple of questions from me. I was thinking in terms of your conversations with dialysis customers and talking about supply and contract pricing for DEFENCATH, could you give a little bit more color on how those are going? You trying to build in certain features to drive DEFENCATH volume in 2026 and beyond? Or how are you thinking about these different levers? Sounds good. And then I had a different question about RIZEAO. It sounds like you are going to share a lot of interesting information with the top line for the Phase III. Could you help frame what in that information you think is most clinically meaningful for physicians? How do you plan to leverage some of this data in potential future discussions with payers, etc., if all goes well and the top line is positive?
Joseph Todisco: Hey, thanks, Roanna. So I would say conversations that I believe are going fairly well. The near-term focus is on preserving patient utilization through the back part of 2026 and creating a structure for an increase in selling price in 2027. And that is what we have been working toward negotiating with customers, and that is what we are hopeful we will be finalizing shortly. We are also setting these up with flexibility to allow for changes in the event we are successful with Medicare Advantage contracting as we progress through this year and into next year. So overall, I am happy with the progress that we have made and hopeful in the near term we will have some things finalized for the back part of the year. Thanks. Before I let Elizabeth comment, I will just give you a little bit of my thoughts. And the way I look at the RIZEAO top-line data, I think there are obviously various degrees of success, right? There is meeting the top-line endpoint and then there are going to be different aspects of pathogen data within the top-line data as well as the secondary endpoint around the discontinuation of the standard of care. And I think, obviously, what we are able to show will guide toward the commercial utility and how we are going to think about marketing and promoting the product. But Elizabeth, do you want to add any further?
Elizabeth Masson-Hurlburt: Sure. Roanna, I think when it comes to how we are going to use the data, a lot of this is going to be dependent on the data that we see in top line. Obviously, the more, the better. I think if we are successful in the way that RESPECT reads out, there is a lot of opportunity for us to be able to talk to the payers about an option that does not have the drug–drug interactions that the azoles and some of the other therapeutics are presenting right now, and we are hopeful that that will lead to understanding around less hospitalizations, getting patients out quickly, and to, you know, more safely be on their cancer regimen. It will be certainly data dependent, but I am confident that once it comes out, we will be able to take a look at that data and strategically place it with payers and the clinical community.
Roanna Clarissa Ruiz: Understood. Thanks.
Operator: And the next question comes from Leszek Sulewski with Truist Securities. Please go ahead.
Jeevan Larson: This is Jeevan on for Les. Thanks for taking our questions. First, any developments on the bipartisan proposed TDAPA extension bills and if the timing here has changed based on recent global events? And then also any updates on a potential partnership with the other LDO and how post TDAPA dynamics change the odds here? Thank you.
Joseph Todisco: Thanks. Look, legislation is always speculative. What I can say is that we have spent a lot of time, we are working closely with the other company that is actively in TDAPA, Akebia. We have been pounding the pavement on the Hill as well as with career staff at CMS and political appointees at CMS. We have a large number of co-sponsors of the bill now. Timing is tricky, right, because this likely needs to be attached to another piece of legislation. There is a war in the Middle East. So we really cannot speculate on whether this can happen before June 30 or December 31. I think if it happens after June 30, I think there is a pathway for potential retroactivity of some aspects of the bill to impact positively on DEFENCATH. That is something we would actively be working on as well behind the scenes. But it is really hard to pinpoint a timing with everything that is going on in Washington right now. With respect to the other LDO, I cannot comment on ongoing discussions with customers.
Operator: And your next question comes from Serge D. Belanger with Needham & Company. Please go ahead.
John Todaro: Hey, good morning. This is John on for Serge today. One on DEFENCATH and then another one on the Melinta product portfolio. So first, just curious if you have any updates on the inpatient opportunity with DEFENCATH. You know, have the sizes of the current contributions been growing and just curious what growth profile you see from this segment in 2026 and 2027? And then on the Melinta portfolio, you mentioned Minocin and Vabomere being, you know, potential significant contributors along with RIZEAO. Curious if there is anything promotionally sensitive that you could kind of reinforce into these products to see some growth in the future?
Joseph Todisco: All right. Thanks, John. And I am not sure I fully understood your DEFENCATH question, but what I will kind of touch on is our guidance and how we constructed our guidance for 2026–2027. So the way we looked at 2026, obviously, the way CMS did the calculation for the bundle adjustment, the $2.37 that goes into the bundle for the third and fourth quarter, it does not fully reimburse providers based on current utilization rates. They used an older period of time to do that calculation that was based on our first year of launch. But we had provisions in our agreements with customers that allow for that type of situation, where there is certain floor pricing under these contracts. What we are working on now is hopefully getting a little bit better than that floor pricing. But our guidance was somewhat based on the floor, and we are working through that process now. Now for 2027, what we wanted to do was give investors comfort that there is at least a base business level of DEFENCATH, which we expect to see price appreciation and hopefully stable volumes based on what we are doing now in the outpatient hemodialysis sector to kind of steady the market with customers. Now we elected not to include in that 2027 guidance potential upside from what we are trying to do with Medicare Advantage contracting with potential new customers both in outpatient hemodialysis and on the inpatient side, because when it comes to guidance, it is very difficult to guide towards something that is still underway in terms of execution. So as we progress throughout the year and should we get a Medicare Advantage contract across the goal line and we have the ability to look and make a forecast around volumes, we would up our guidance accordingly as we progress through the year.
John Todaro: On the Melinta portfolio question,
Joseph Todisco: look, I think Minocin and Vabomere are two really good durable products that have entrenched utilizations in the hospital inpatient segment for treatments of niche infections, right? I think Minocin is closing in at around $50,000,000 in sales. Vabomere is just under $30,000,000. So we do have a little bit of promotional efforts on there. We do not think that they are usually promotionally sensitive the way a launch product would be. But we think there is a couple of percentage points of growth there that we expect to get this year.
John Todaro: That is helpful. Thanks.
Operator: And your next question comes from Brandon Richard Folkes with H.C. Wainwright. Please go ahead.
Brandon Richard Folkes: Hi, thanks for taking my questions and congrats on the quarter. Maybe just two from me. Firstly, DEFENCATH, can you just talk about the customer mix currently and whether you anticipate any change of that in your 2026 and 2027 guidance? How should we think about the opportunity in the other mid-sized operators for DEFENCATH? And if I just ask one more. I know you mentioned you filed the 10-Ks, sorry, have not been through it. But can you just talk about the operating cash flow in the quarter? It looked very strong. So just anything to consider there? And then also how we should think about it in 2026? Thank you.
Joseph Todisco: So right now, I would say we are fairly heavily concentrated volume-wise with one of the LDOs and then two of the three mid-sized players are driving probably 90-something percent of our volume amongst the three of them. There is a third mid-sized provider that is utilizing but not at the scale of others. And then we have a number of small accounts that, even if they are utilizing it fairly broadly, do not represent as large of a market impact, as they may only have 20 clinics or 15 clinics. So that is certainly kind of the mix today. Now, terms of changes we would anticipate in 2026 and 2027 would depend in large extent on our ability to onboard either the other LDO or to get the third mid-sized player to meaningfully increase volume. So those are the only things that would really, I think, change the mix in any meaningful fashion. What we are doing on the inpatient side in terms of promoting DEFENCATH, while that is a good dollar market opportunity, we believe the volumes there would be much lower from a volume distribution standpoint. So I hope that answers the question. Yes. Look, I think roughly, we would like to say that EBITDA could be a proxy for cash flow for the year. I think there are some items that could impact in terms of our need to maybe stockpile some inventory this year as we are working through a few tech transfers. We also have some rebates, large accrued rebates that you will see on the balance sheet, that will get paid out in the early part of this year. So those are kind of really the big items that impact cash flow. Susan, anything you want to add to that?
Susan Blum: No, you covered it, Joseph.
Brandon Richard Folkes: Great. Thanks very much.
Operator: This concludes our question and answer session. This concludes today's conference call. Thank you for attending today's presentation. You may now disconnect.