CorMedix Q4 2025 Earnings Call - DefenCath guidance affirmed as TDAPA shifts to bundled add-on, REZZAYO Phase 3 readout set for Q2 2026

Unknown, Conference Call Operator, CorMedix: Good morning, and welcome to the CorMedix 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 Dan Ferry from LifeSci Advisors. Please go ahead.

Dan Ferry, Moderator/Operator, LifeSci Advisors: Good morning, and welcome to the CorMedix 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, 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, Mike Seckler, EVP and Chief Commercial Officer, and Dr. Matt 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 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. 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 in the current report on Form 8-K filed with the SEC. This information is also available on the investor relations section of CorMedix website. At this time, it is now my pleasure to turn the call over to Joe Tedesco, Chairman and Chief Executive Officer of CorMedix. Joe, please go ahead.

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. 2025 was truly a transformational year for CorMedix. While DefenCath achieved peak sales of just under $260 million, 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 million during the fourth quarter of 2025. This was a monumental achievement and truly a testament to the operational execution capabilities of the CorMedix 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 of this year, the TDAPA reimbursement for DefenCath will transition from a buy and bill format to a bundled add-on mechanism. We’ve had multiple conversations with our top customers and are in the process of finalizing supply pricing for Q3 and Q4 of 2026 as well as for 2027. At this time, we are affirming our 2026 DefenCath guidance of $150 million-$170 million and 2027 DefenCath guidance of $100 million-$125 million. 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 third and fourth quarter.

Assuming CMS utilizes the same methodology to calculate the 2027 bundle edition, 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 and Q4 of 2026. To that extent, we took the extra step of issuing 2027 DefenCath guidance, which is based on existing patient utilization rates as well as our current estimates for the range of net selling prices and does not include potential upside from new customers or managed care contracting. The company is also affirming its full year 2026 financial guidance of revenue of $300 million-$320 million and Adjusted EBITDA of $100 million-$125 million.

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 REZZAYO, MINOCIN and BAXDELA, and we’ll evaluate appropriate updates to financial guidance as we progress throughout 2026. This past month, we completed our first analyst R&D day, in which we focused on educating our analysts and investor community on the market opportunity for our antifungal product, REZZAYO, in its current approved indication in the treatment of invasive fungal infections, as well as our key pipeline assets of REZZAYO in development for prophylaxis of invasive fungal infections and DefenCath in development for prevention of CLABSI in adult patients receiving Total Parenteral Nutrition. Liz 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. The webcast of the event and associated materials remains available on our website, 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 REZZAYO, which we estimate at approximately two and a half billion dollars across both potential indications, and for DefenCath and TPN, which we estimate between $500 million and $750 million. 2026 is expected to be a transitional year for CorMedix, with a heightened investor focus on new catalysts and value drivers, most notably our phase 3 ReSPECT data for REZZAYO and 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 REZZAYO, but also added highly durable institutional investor 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 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’d now like to turn the call over to our Chief Operating Officer, Liz Hurlburt, to provide an update on clinical activities. Liz, please go ahead.

Liz Hurlburt, EVP and Chief Operating Officer, CorMedix: Thank you, Joe. 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 3 ReSPECT study evaluating REZZAYO for the prophylaxis of fungal infections 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 the second quarter of 2026.

Top-line results will include the primary efficacy outcome of fungal-free survival at day 90, discontinuation of study drugs 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. Safety data, including overall adverse events, treatment emergent adverse events, and serious adverse events, is 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 Joe 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. We are looking forward to our phase 3 data readout. Turning to DefenCath, I’m pleased to share that the phase 3 Nutriguard clinical study, which is evaluating the impact on central line-associated bloodstream infections, or CLABSI, for 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 of the Nutriguard study allows for a minimum of 90 and 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, EVP and Chief Financial Officer, CorMedix: Thanks, Liz. 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 August 29th, 2025, the fourth quarter of 2025 represents the first full reporting period incorporating Melinta’s operations into our consolidated results. The company has filed its annual report on Form 10-K for the year ended December 31st, 2025. I encourage you to review this filing for a more comprehensive discussion of our financial re-performance and operating results. As Joe mentioned, we had a strong quarter on the revenue front.

For the fourth quarter, net 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 $31.2 million in the fourth quarter of 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 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 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 3 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. Today we 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 and preparation for the anticipated new launch opportunities of DefenCath and TPN and REZZAYO for prophylaxis. On the bottom line, CorMedix recognized net income of $14 million in the 4th quarter of 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 the 3rd quarter of 2025.

On a pre-tax basis for the fourth quarter, income was $56.4 million, an increase of $43 million from the fourth quarter of 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 benefits and expenses recognized during the year. It provides additional insight into the strengths 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’m excited to be a part of the journey as we move forward. Now I will turn the call back to Joe for closing remarks. Joe?

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: Thanks, Susan. As I mentioned, 2025 was a transformational year, and 2026 will be a transitional year that we believe sets up CorMedix for long-term sustainable growth in 2027 and beyond. We recently announced the share repurchase program and have been active in 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 and our path to future growth and sustained profitability. I would like to now open up the call for Q&A.

Unknown, Conference Call Operator, CorMedix: We will now begin the question and answer session. To ask a question, you may press Star, then 1 on your telephone keypad. If you’re using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press Star, then 2. The first question today comes from Roanna Ruiz with Leerink. Please go ahead.

Roanna Ruiz, Analyst, Leerink: Hey. Morning, everyone. A couple questions for me. I was thinking in terms of your conversations with dialysis customers and talking about supplying contract pricing for DefenCath, could you give a little bit more color how those are going? Are you trying to build in certain features to drive DefenCath volume in 2026 and beyond? Or how are you thinking about these different levers?

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: Hey, thanks, Roanna. I believe conversations 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. That’s what we’ve been working toward negotiating with customers, and that’s what we’re hopeful we’ll 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. Overall, I’m happy with the progress that we’ve made and hopeful in the near term, we’ll have some things finalized for the back part of the year.

Roanna Ruiz, Analyst, Leerink: Sounds good. I had a different question about REZZAYO. It sounds like you’re gonna share a lot of interesting information with the top line for the phase 3. 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, et cetera, if all goes well and the top line is positive?

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: All right, thanks. Before I let Liz comment, I’ll just, you know, give you a little bit of my thoughts. You know, the way I look at the REZZAYO top-of-line data, I think there’s obviously various degrees of success, right? There’s meeting the top-line endpoint, and then there’s gonna be, you know, different aspects of the pathogen data within the top-line data as well as, right, secondary endpoint, around the discontinuation of the standard of care. I think, you know, obviously what we’re able to show will guide toward, right, the commercial utility and how we’re gonna think about marketing and promoting the product. Liz, do you wanna comment any further?

Liz Hurlburt, EVP and Chief Operating Officer, CorMedix: Sure. You know, Rowena, I think when it comes to how we’re gonna use the data, a lot of this is gonna be dependent on the pathogens 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. We’re hopeful that that will lead to understanding around less hospitalizations, getting patients out quickly and to, you know, more safely be on their anticancer regimen.

It’ll be certainly data dependent, but, I’m confident that once it comes out, we’ll be able to take a look at that data and strategically place it with payers and the clinical community.

Roanna Ruiz, Analyst, Leerink: Understood. Thanks.

Unknown, Conference Call Operator, CorMedix: Your next question comes from Les Sulewski with Truist Securities. Please go ahead.

Jeevan, Analyst, Truist Securities: Hey, this is Jeevan on for Les. Thanks for taking our questions. First, any developments on the bipartisan proposed TDAPA extension bills and, you know, if the timing here has changed based on recent global events? Also, any updates on a potential partnership with the other LDO and how post-TDAPA dynamics change the odds here? Thank you.

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: Thanks. Look, legislation is always speculative. What I can say is that, you know, we’ve spent a lot of time. We’re working closely with the other company that’s actively in TDAPA, Akebia. We’ve been pounding the pavement on the Hill as well as with, you know, career staff at CMS, political appointed staff at CMS. We’ve got a large number of co-sponsors of the bill. Timing is tricky, right? Because this likely needs to be attached to another piece of legislation. There’s a war in the Middle East. We really can’t speculate on whether this, you know, can happen before June 30th or December 31st.

I think if it, if it happens after June 30th, I think there is a pathway for potential retroactivity of some aspects of the bill to impact positively on DefenCath. That’s something we’d actively be working on as well behind the scenes. It’s really hard to, you know, to kind of pinpoint a timing with everything that’s going on in Washington right now. You know, with respect to the other LDO, I can’t comment on ongoing discussions with customers.

Unknown, Conference Call Operator, CorMedix: Your next question comes from Serge Belanger with Needham & Company. Please go ahead.

John, Analyst, Needham & Company: Hey, good morning. This is John on for Serge today. One on DefenCath and then another one on the Melinta product portfolio. 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? Just curious what growth profile you see from this segment in 2026 and 2027. On the Melinta portfolio, you mentioned MINOCIN and VABOMERE being, you know, potential, you know, significant contributors along with REZZAYO. Curious if there’s, you know, anything promotionally sensitive that you could kind of reinforce into these products to see some growth in the future. Thanks.

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: All right. Thanks, John. I’m not sure I fully understood your DefenCath question, but what I’ll kind of touch on is our guidance and how we constructed our guidance for 2026 and 2027. You know, the way we looked at 2026, obviously with 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 doesn’t fully reimburse providers, right? For 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.

We have provisions in our agreements with customers that allow for that type of situation, where, you know, there are certain floor pricing under these contracts. What we’re working on now is hopefully getting a little bit better than that floor pricing. Our guidance was somewhat based on the floor, right? We’re working through that process now. Now for 2027, what we wanted to do was give investors comfort that there’s at least a base business level of DefenCath for which we expect to see price appreciation and hopefully stable volumes based on what we’re doing now in the outpatient hemodialysis sector to kind of steady the market with customers.

You know, we elected not to include in that 2027 guidance potential upside from what we’re trying to do with Medicare Advantage contracting, with potential new customers both in outpatient hemodialysis and on the inpatient side. When it comes to a guidance, it’s very difficult, right, to guide towards something that is still under the way in terms of, right, execution, right? You know, as we progress throughout the year and, you know, 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 update our guidance accordingly as we progress through the year. On the Melinta portfolio question.

Look, I think MINOCIN and VABOMERE are two really good durable products that have entrenched utilizations in the hospital inpatient segment for treatments of, you know, niche infections, right? I think, you know, MINOCIN is closing in at around $50 million in sales. VABOMERE is just under $30 million. We do have a little bit of promotional efforts on there. We don’t think that they are usually promotionally sensitive the way a launch product would be, but we think there’s a couple percentage points of growth there that we expect to get this year.

Brandon Folkes, Analyst, H.C. Wainwright: That’s helpful. Thanks.

Unknown, Conference Call Operator, CorMedix: Your next question comes from Brandon Folkes with H.C. Wainwright. Please go ahead.

Brandon Folkes, Analyst, H.C. Wainwright: Hi, thanks for taking my question, and congrats on the quarter. Maybe just two from me. Firstly, on 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?

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: Right now, I’d say we’re fairly heavily concentrated volume-wise with one of the LDOs and then two of the three mid-sized players are driving probably 90-something% of our volume amongst the three of them. There’s a third mid-sized provider that’s utilizing, but not at the scale of others. We have a number of small accounts that, even if they’re utilizing it fairly broadly, they don’t represent as large of a market impact because they may only have 20 clinics or 15 clinics. That’s certainly kind of the mix today.

In terms of changes we would anticipate in 26 and 27, right, would depend in large extent to our ability to onboard either the other LDO or to get the third mid-sized player to meaningfully increase volume. The only things that would really kinda, I’d say, change the mix in any meaningful fashion. You know, what we’re doing on the inpatient side in terms of promoting DefenCath, while that’s a good dollar market opportunity, we believe the volumes there would be much lower, right, from a volume distribution standpoint. I hope that answers the question.

Brandon Folkes, Analyst, H.C. Wainwright: That does. If I just may ask one more. I know you mentioned you filed the Form 10-K, so I haven’t been through it. Can you just talk about the operating cash flow in the quarter? It looked very strong. Just, you know-

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: Yeah.

Brandon Folkes, Analyst, H.C. Wainwright: Anything to consider there, and then also maybe how we should think about it in 2026. Thank you.

Joseph Todisco, Chairman and Chief Executive Officer, CorMedix: Look, I think roughly, you know, we like to say that, you know, the EBITDA is could be a proxy for cash flow for the year. I think there’s some items that could impact in terms of our need to maybe stockpile some inventory this year as we’re working through a few tech transfers. We also have some rebates that large accrued rebates that you’ll see on the balance sheet that’ll get paid out in the early part of this year. Those are kind of really the big items that impact cash flow. Susan, anything you wanna add to that?

Brandon Folkes, Analyst, H.C. Wainwright: No, you covered it, Joe. Great. Thanks very much.

Unknown, Conference Call Operator, CorMedix: This concludes our question and answer session and today’s conference call. Thank you for attending today’s presentation. You may now disconnect.