On Thursday, Cormedix (NASDAQ:CRMD) discussed second-quarter financial results during its earnings call. The full transcript is provided below.

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Summary

Cormedix reported second quarter revenue of $101.9 million, with an adjusted EBITDA of $58.7 million, reflecting strong demand for DefenCath and contributions from the acquired Melinta portfolio.

The company signed a multi-year commercial supply agreement for DefenCath with another large dialysis organization, covering all top five U.S. dialysis providers, and anticipates expansion in 2027.

Cormedix reaffirmed its 2026 revenue guidance of $325 million to $345 million and increased its adjusted EBITDA guidance to $125 million to $140 million.

Positive Phase 3 RESPECT data for Rezzayo, a potential prophylaxis treatment for invasive fungal disease, positions it for a possible 2027 FDA decision, with commercial preparations underway.

Operating expenses increased year-over-year due to the acquisition of the Melinta portfolio and higher personnel costs, while cash and cash equivalents stood at $256.7 million at the end of the quarter.

Real-world evidence and ongoing studies continue to support the clinical and economic benefits of DefenCath, with upcoming data presentations planned at major medical conferences.

Full Transcript

OPERATOR (Operator)

Good morning and welcome to the Cormedix second quarter 2026 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, LifeSci Advisors

Good morning and welcome to the Cormedix second quarter 2026 earnings and corporate update conference call. Leading the call today is Joe Tedisco, Chairman and Chief Executive Officer of Cormedix. He is joined by Liz Hurlbert, EVP and Chief Operating and Commercial Officer, and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnik Coffin, EVP and Chief Legal and Compliance Officer and Corporate Secretary, and Dr. Matt David, EVP and Chief Business Officer, are on the line and will be available during the Q and 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 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. 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's earnings release and the current report on Form 8-K filed with the SEC.

This information is also 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 Tedisco, Chairman and Chief Executive Officer of Cormedix. Joe, please go ahead.

Joe Tedisco, Chairman and Chief Executive Officer

Thank you, Dan. Good morning everyone and thank you for joining us on this call. In the second quarter, we continued to execute on our core strategic initiatives, solidifying DefenCath's market position as we navigate the evolving post-TDAPA landscape, meaningfully advancing our high value pipeline highlighted by the positive Phase 3 RESPECT data for Rezzayo and now working collaboratively with Mundipharma towards their submission of the sNDA for Rezzayo in the prophylaxis of invasive fungal disease, and lastly deploying our capital in a disciplined manner to drive long term value for shareholders while building an increasingly diversified and resilient business. We announced this morning second quarter consolidated revenue of $101.9 million, adjusted EBITDA of $58.7 million. Susan will provide more granular details of second quarter financial results today. We also announced that we've signed a multi-year commercial supply agreement for DefenCath with an additional large dialysis organization, or LDO. With this agreement, Cormedix now has commercial supply agreements in place with all five of the top dialysis providers in the U.S. The newly signed LDO has placed an initial order and will initially begin a pilot of DefenCath in the third quarter of this year with a potential opportunity to expand utilization in 2027. We view the signing of this agreement as an important milestone and validation of DefenCath's clinical value proposition. With the largest providers in the U.S. dialysis market turning to guidance, we are reaffirming our full year 2026 revenue guidance with a range of $325 million to $345 million and raising our full year adjusted EBITDA guidance to a new range of $125 to $140 million.

We will revisit guidance as the year progresses and as we gain additional visibility into post-TDAPA ordering patterns. While we're only a few weeks into the third quarter, DefenCath order volumes in July have tracked consistent with the post-TDAPA forecast underlying our financial guidance. In addition to the new LDO agreement, we have signed contract amendments with our major customers covering third and fourth quarter 2026 pricing and in some instances pricing and volume commitments for 2027.

These amendments give us improved visibility into pricing and utilization through year end and are designed to keep patients on therapy through the reimbursement transition. We continue to focus significant internal resources on the DefenCath growth strategy through Medicare Advantage contracting and I'm pleased with the progress of those discussions to date. Contracting cycles with these plans can be lengthy and we have not assumed a contribution from Medicare Advantage in our 2026 guidance.

We continue to believe Medicare Advantage represents a meaningful long term growth avenue for DefenCath. DefenCath's clinical value and its potential for meaningful downstream cost savings continue to be supported by a growing body of real-world evidence that our partners are publishing, and we anticipate additional data presentations this fall at the American Society of Nephrology's Kidney Week and at ID Week. Turning to our pipeline, we announced the positive Phase 3 RESPECT data in patients undergoing allogeneic bone marrow transplant.

We believe these results position Rezzayo, if approved, to become an attractive option for clinicians in the prophylaxis of invasive fungal disease, or IFD. Assuming timely submission and FDA acceptance of the filing, we would anticipate agency action in the first half of 2027. As we begin to prepare our commercial infrastructure for potential launch of Rezzayo for prophylaxis, we expect to incur incremental spend in the back half of the year, including the anticipated addition of 15 to 20 positions across both commercial and medical.

These investments are sized to allow us to move quickly at approval while preserving flexibility if regulatory timelines shift and are already reflected in our narrowed full year cash opex guidance of $145 to $155 million. As a reminder, our cash opex guidance excludes non-cash charges such as stock-based compensation. I would now like to turn the call over to our Chief Operating and Commercial Officer, Liz Hurlbert, to provide an update on clinical activities.

Liz, please go ahead.

Liz Hurlbert, EVP and Chief Operating and Commercial Officer

Thank you, Joe, and good morning everyone. As Joe mentioned, we were pleased to announce preliminary top-line results of the RESPECT Study at the end of April and, following a pre-NDA meeting with the FDA, are working diligently with our partner Mundipharma in support of their submission of the sNDA for Rezzayo in prophylaxis in the third quarter. As a reminder, the RESPECT Study met its primary endpoint of fungal-free survival at day 90, showing non-inferiority versus the standard antifungal regimen, meeting the prespecified non-inferiority margin.

In addition, results showed a favorable profile across multiple secondary endpoints, most notably in treatment-emergent adverse events leading to dose reduction, interruption or withdrawal of study drug, and study discontinuation. As we stated previously, the objective with the RESPECT Study was to show comparable efficacy to standard of care while also demonstrating a favorable overall safety profile with regard to drug–drug interactions and toxicity.

We believe the study has achieved this objective and that the results position Rezzayo, if approved, as a differentiated option for prophylaxis of IFD with a meaningful potential commercial opportunity. It's important to remember that this was a global study conducted by our partner Mundipharma, who owns global rights and will pursue regulatory approvals outside of the United States. Mundipharma is currently the holder of the U.S. NDA and, under the terms of our agreement, transfers ownership of the NDA to Cormedix following approval of an sNDA for the prophylaxis indication, at which point Cormedix would own and control the U.S. asset. Under our agreement, the parties must work together on the publication of data and any submissions to FDA. In terms of data publication, we currently expect additional data from the Phase 3 RESPECT Study to be published later this year at one or more medical conferences during the fourth quarter. Turning to DefenCath, we also expect additional real-world evidence to be published in the fourth quarter, with multiple abstracts having been submitted to both ASN and IDWeek.

Assuming acceptance, these publications will present the final results from the U.S. Renal Care real-world evidence study, which at interim analysis showed a meaningful impact on infection-related hospitalizations and catheter-related bloodstream infection, as well as two other external studies. The first will highlight the demonstrated efficacy of DefenCath when used in combination with chlorhexidine antimicrobial caps and the second is expected to highlight the clinical and economic benefits of DefenCath in the outpatient hemodialysis setting related to a meaningful reduction in TPA use by facilities.

All combined, we expect that these data will add to the growing body of evidence supporting the clinical and pharmacoeconomic value of DefenCath. Shifting gears to our Phase 3 TPN study, we recently submitted a protocol amendment to FDA that narrows certain exclusion criteria which we believe can support increased enrollment in the coming months, and we have additionally activated additional sites. We will continue to update investors on our progress as we move through the year and we continue to expect study completion in 20.

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

Susan Blum, EVP and Chief Financial Officer

Thanks, Liz, and good morning everyone. We are pleased to announce our second quarter results which reflect strong execution across the business, continued demand for DefenCath, and the contribution from the acquired Melinta portfolio. As a reminder, because the Melinta acquisition closed in August 2025, the second quarter of 2026 includes a full quarter of Melinta operations while the second quarter of 2025 does not. Accordingly, year-over-year comparisons are heavily influenced by the broader product portfolio and cost structure of the combined company.

We also filed our Form 10-Q this morning and I encourage investors to review it for additional details and important disclosures. Turning to the numbers, second quarter 2026 consolidated revenue was $101.9 million, compared with $39.7 million in the second quarter of 2025. Second quarter revenue included $66.1 million in sales of DefenCath and $35.8 million in revenue associated with the acquired Melinta portfolio. DefenCath sales increased year over year, largely due to the onboarding of a large dialysis customer in mid-2025.

Operating expenses were $34.2 million in the quarter, compared with $18.3 million in the second quarter of 2025, an increase of approximately 87%. The increase of $15.9 million over the prior year period was driven primarily by the acquisition in the second quarter of 2026 compared with $2.4 million for the same period in 2025. The increase was due primarily to higher personnel and clinical trial services in support of ongoing clinical programs, including pediatric studies for several brands, and continued investment in the development of DefenCath for the TPN indication.

Selling and marketing expense increased approximately 95% to $12.4 million in the second quarter of 2026 from $6.4 million in the second quarter of 2025. The increase was due primarily to higher personnel costs associated with a larger product portfolio and related marketing programs. General and administrative expenses increased approximately 59% to $15.1 million in the second quarter of 2026 from $9.5 million in the second quarter of 2025. The increase was driven by higher costs associated with operating as a combined company following the acquisition, including branded prescription drug fees and higher personnel, information technology, legal and facilities costs. G&A expenses in the quarter also reflect a reduction to expense of $4.2 million, which represents the amount of expected insurance reimbursement of legal fees incurred by the company to support its ongoing securities litigation. Of the $4.2 million credit recorded in the second quarter, $2.7 million related to legal fees that were incurred in prior periods. On the bottom line, Cormedix recorded net income of $26.0 million, or $0.33 and $0.29 per basic and diluted share, respectively, in the second quarter of 2026 compared with net income of $19.8 million, or $0.29 and $0.28 per basic and diluted share, respectively, in 2Q2025.

In addition to net revenue and operating expenses, EPS was impacted by income tax expense of $12.7 million as well as non-operating income and expenses, net, of approximately $4.2 million associated with the mark-to-market of marketable equity securities and contingent considerations, which reflects the approximate fair value of future milestones and royalties payable to former Melinta shareholders. On a non-GAAP basis, adjusted EBITDA was $58.7 million for the second quarter of 2026 compared with adjusted EBITDA of $22.4 million in the second quarter of 2025.

This adjusted EBITDA metric excludes non-cash items such as depreciation and amortization. We ended the second quarter with $256.7 million in cash and cash equivalents. For the six months of 2026, net cash provided by operating activities was $128.6 million, compared with $49.7 million for the first six months of 2025. As Joe mentioned, we are confident in our fiscal year 2026 financial guidance which includes full year 2026 consolidated revenue of $325 million to $345 million, full year DefenCath revenue guidance of $175 million to $195 million, and revised full year adjusted EBITDA guidance of $125 million to $140 million.

We continue to believe we are well positioned with a strong balance sheet, meaningful cash generation and the financial flexibility to support our operating priorities, pipeline development and shareholder value creation. And now I will turn the call back to Joe for closing remarks.

Joe Tedisco, Chairman and Chief Executive Officer

Thank you, Susan. I'm confident where the company stands today and the opportunity ahead of us. Cormedix has built meaningful momentum through the first half of 2026 across all three pillars of our investment thesis. First, DefenCath continues to perform in line with our internal expectations at the TDAPA expiration, demonstrating durable underlying utilization which we believe positions the franchise to remain a meaningful value generator following the reimbursement transition.

Second, we are advancing a pipeline of high value late-stage opportunities including Rezzayo for prophylaxis and DefenCath in TPN which could meaningfully expand our long term revenue opportunity. And third, we have delivered significant profitability and cash generation over the last year, $277.8 million of adjusted EBITDA over the trailing 12 months and $267 million of combined cash and investments at quarter end, which allows us to reinvest in growth and pursue business development opportunities.

We remain confident in our outlook for this year and our path to sustained growth and profitability beyond it. This concludes our prepared remarks and I'll ask the operator to open up now for questions.

OPERATOR (Operator)

We will now begin the question and answer session. To ask a question you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time we will pause momentarily to assemble our roster. Our first question comes from Roanna Ruiz with Leerink Partners.

Please go ahead.

Anna, Analyst on behalf of Roanna Ruiz at Leerink Partners

Hi guys, this is Anna on for Roanna. Thanks so much for taking our question and congrats on the progress. Just wanted to check in on how the new multi-year agreement with the LDO is expected to impact your 2027 expectations and if you could give any color on how long it takes for a new site to reach the steady state production in line with other operators. And I have a follow up.

Joe Tedisco, Chairman and Chief Executive Officer

Okay, thanks, Anna. So, you know, we just recently signed that agreement and they're rolling out a pilot. We, you know, we're waiting to see kind of actually what they're looking for and we're hopeful for additional utilization. So once we get better visibility, you know, we'll be in a position probably to talk more about 2027. There's a lot of variables that go into 27 guidance. I don't expect we'll be in a position to comment on it until either late this year or early next year.

So there's just a lot of pushes and pulls. We don't have any cause now to either adjust the top or bottom of that guidance. But as we move through the year and we get better visibility, we can provide updates.

Anna, Analyst on behalf of Roanna Ruiz at Leerink Partners

Sure, thanks. And is any of that LDO pilot included in the 2026 guidance?

Joe Tedisco, Chairman and Chief Executive Officer

No, no. Right now it's—well, obviously it's tracked in the revenue, so it's within the revenue that we're seeing from the pilot, is within our existing guidance. And for DefenCath, we are right now tracking to the kind of mid to top part of the DefenCath guidance. So, you know, let's see where we go through the year and, as I said, we'll update, you know, as we go.

Anna, Analyst on behalf of Roanna Ruiz at Leerink Partners

Great, thanks so much.

OPERATOR (Operator)

Our next question comes from Leonid Timoshev with RBC Capital Markets. Please go ahead.

Leonid Timoshev, Analyst at RBC Capital Markets

Hey guys, thanks for taking my question. I want to ask on maybe if you can comment on what you're seeing in terms of volume growth in the existing channels thus far in this quarter, just given that we're in the post-TDAPA period now, and then related to that, just as a follow up, how are you thinking about the potential for the final ESRD guidance to increase the payment? Thanks.

Joe Tedisco, Chairman and Chief Executive Officer

All right, thanks, Leo. So, look, in terms of volume growth, I think what we're seeing in July is really kind of stabilized volumes with the larger players, which is what we expected, and some attrition with the really small players, which is also what we expected. I think to really see volume growth in DefenCath, one of two things can happen. The new LDO is going to have to come in meaningfully with some adoption and/or Medicare Advantage contracting.

I think we're cautiously optimistic, we're making good progress, that perhaps we have something in place that takes effect early next year and starts to really impact DefenCath volumes. Those are really the two levers that I see from a DefenCath standpoint. Now, the final ESRD rule—obviously they put out the proposed rule. It was a little bit different than what we were expecting in terms of the quarterly mechanism. I expect there's going to be a lot of comment on that.

Not sure if that's actually what will make it into the final rule, but, you know, we'll expect the final rule.

OPERATOR (Operator)

Our next question comes from Jason Butler with Citizens. Please go ahead.

Jason Butler, Analyst at Citizens

Hi. Thanks for taking the questions. First one, can you give any more color on the size or scope of the pilot study being conducted by the new LDO? And then for Rezzayo in prophylaxis, can you talk about, since you had the Phase 3 results, the feedback you're getting from potential prescribers—just what the reception to that data has been as you think about a potential label expansion? Thank you.

Joe Tedisco, Chairman and Chief Executive Officer

Yeah, look, right now, the size and scope of the pilot—we shipped an initial order. We think it's a couple hundred clinics. We'll see where we can go from there. I don't want to get out over my skis on the pilot yet, Jason. So we're just—right now we're really happy to have finally gotten that LDO kind of over the hump and to the point of commercialization. So we're taking that one day by day. On Rezzayo, the full data set is not yet out, so we really haven't been able to conduct robust market research.

As we said in the script, we are working with our partner, Mundipharma. We would expect it to be published later in the fourth quarter at one or more medical conferences. And once we have that data available, we'll be able to have more substantive discussions around the data itself with clinicians.

Jason Butler, Analyst at Citizens

Great, thank you.

Serge, Analyst

I guess, first on the new LDO—first, congratulations. Even if it's just a pilot program, I guess my question is why did the LDO decide to enter an agreement now when the product's been available for two years? And I know the company had some meaningful efforts to sign them up. Secondly, on Rezzayo, following your FDA meeting, just curious what your expectations are for potential labeling of the product. I believe a Phase 3 trial was conducted in allogeneic HSCT patients.

Curious if you'll be able to address the broad patient population that could benefit from Rezzayo.

Joe Tedisco, Chairman and Chief Executive Officer

Thanks, Serge. Look, on the new LDO, I really can't speak to the motivations of the company in terms of timing. Obviously, we have built a wealth of real-world evidence around the clinical efficacy and the pharmacoeconomic benefits of DefenCath, and, as I said, we're happy that they are choosing to begin implementation of DefenCath. On Rezzayo, look, it's going to be a label review issue. So until we work through this process, just coming out of the pre-NDA meeting, we don't have yet visibility into what the final label will be.

OPERATOR (Operator)

Our next question comes from Brandon Folkes with H.C. Wainwright. Please go ahead.

Brandon Folkes, Analyst at H.C. Wainwright

Hi. Thanks for taking my question and congrats on the progress. Maybe just one from me. Can you just talk about the SG&A in the quarter and the updated guidance? You know, did you take any actions in the quarter, whether it's—especially on the sales and marketing infrastructure—just on DefenCath or the existing Melinta portfolio? Just any color there on the expense discipline on the SG&A line. Thank you.

Joe Tedisco, Chairman and Chief Executive Officer

Thanks, Brandon. I'll let Susan comment. We didn't take any deliberate actions. We're obviously trending a little bit light on the expense side. Some of the staffing that we're bringing on is coming in later in the year.

Susan Blum, EVP and Chief Financial Officer

Yeah, and also we did—and we disclosed this in our Form 10-Q—we had a reduction of G&A for $4.2 million in the quarter, so it's reflecting artificially low because of that. $2.7 million of that was incurred primarily in Q1 of 2026. So we added the deductible under our insurance policies for the litigation costs, so we were able to claim the reimbursement of those, and that's what we recorded in the second quarter. So it essentially eliminates those litigation legal fees that we had incurred in Q1 and in Q2 during the second quarter.

So if you think about the run rate for expenses, it would be—maybe it would be $2.7 million higher because of what we reversed from prior periods. Does that make sense?

Brandon Folkes, Analyst at H.C. Wainwright

It does. And then just to confirm, so, you know, there's been no actions taken on the DefenCath sales and marketing infrastructure ahead of sort of the lower reimbursement period. There's no action taken in the company? Perfect. Thank you very much, and congrats on the progress.

OPERATOR (Operator)

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

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