CRMD

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 8:30 a.m. ET Chairman and Chief Executive Officer - Joseph Todisco EVP and Chief Operating and Commercial Officer - Elizabeth Masson-Hurlburt EVP and Chief Financial Officer - Susan Blum EVP and Chief Legal and Compliance Officer and Corporate Secretary - Beth Zelnick Kaufman EVP and Chief Business Officer - Matt David Operator: Good morning, and welcome to the CorMedix Second Quarter 2026 Earnings and Corporate Update Conference Call. Today's conference call is being recorded. [Operator Instructions] At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. Please go ahead. Daniel Ferry: Good morning, and welcome to the CorMedix Second Quarter 2026 Earnings and Corporate Update Conference Call. Leading the call today is Joe Todisco, Chairman and Chief Executive Officer of CorMedix. He is joined by Liz Hurlburt, EVP and Chief Operating and Commercial Officer, and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnick Kaufman, 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&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. An investor 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 Todisco, Chairman and Chief Executive Officer of CorMedix. Joe, please go ahead. Joseph Todisco: 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 III 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 fuel sustainable growth and new business development opportunities. We believe this combination of commercial execution, pipeline progression and strategic capital allocation positions CorMedix 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 and 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 5 of the top dialysis providers in the U.S. The newly signed LDO has placed 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 million 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 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 for 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 IDWeek. Turning to our pipeline. We announced this morning that we anticipate the submission of the sNDA for REZZAYO in prophylaxis in the third quarter of this year. This follows last quarter's announcement of positive preliminary top line clinical trial results from the ReSPECT study, a Phase III clinical study evaluating REZZAYO for the prophylaxis of invasive fungal disease in adult immunosuppressed patients undergoing allogeneic bone and 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 a 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 million 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 Hurlburt to provide an update on clinical activities. Liz, please go ahead. Elizabeth Masson-Hurlburt: 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 constructive 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 for FDA of fungal-free survival at day 90, showing non-inferiority versus the standard antifungal regimen, or SAR, meeting the pre-specified 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 drugs, 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 IP 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. assets. 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 III ReSPECT study to be published later this year at 1 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 infections, as well as 2 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 III 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 2028. I would now like to turn the call over to Susan to discuss the company's second quarter financial results and financial position. Susan? Susan Blum: Thank you, 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 did 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 contribution of operating expenses from the Melinta acquisition for the full quarter and reflects the larger combined company. Research and development expenses were $6.7 million 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 investments in the development of DefenCath for the TPN indications. Sales 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 reflects 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 reported in the second quarter, $2.7 million is the amount of credit that the company has incurred 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 the second quarter of 2025. 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 consideration, which reflects the approximate fair value of future milestone 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, amortization, and stock-based compensation, interest and other income and expense net, taxes and certain non-recurring items. We ended the second quarter with $256.7 million in cash and cash equivalents. For the first 6 months of 2026, net cash provided by operating activities was $128.6 million, compared with $49.7 million for the first 6 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? Joseph Todisco: Thank you, Susan. I'm confident where the company stands today and in the opportunity ahead of us. CorMedix has built meaningful momentum through the first half of 2026 across all 3 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're 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 in 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: We will now begin the question and answer session. [Operator Instructions] Our first question comes from Roanna Ruiz with Leerink. Please go ahead. Unknown Analyst: This is Anna on for Roanna. 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 this steady state production in line with other operators. And I have a follow-up. Joseph Todisco: Okay, thanks, Anna. So we just recently signed that agreement and they're rolling out a pilot. 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, we'll be in a position probably to talk more about 2027. There's a lot of variables that go into 2027 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. Unknown Analyst: Sure, thanks. And is any of that LDO pilot included in the 2026 guidance? Joseph Todisco: No, no, right now it's, well obviously it's tracking 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-top part of the DefenCath guidance. So let's see where we go through the year. And as I said, we'll update as we go. Operator: Our next question comes from Leonid Timashev with RBC Capital Markets. Leonid Timashev: 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 final ESRD guidance to increase the payment? Joseph Todisco: 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, you know, perhaps we have something in place that takes effect early next year and starts to really impact the DefenCath volumes. Those are really the 2 levers that I see, you know, from the 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 we'll expect the final rule in November, and then we will adjust accordingly. Operator: Our next question comes from Jason Butler with Citizens. Jason Butler: 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 and prophy, can you talk about, since you had the Phase III 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? Joseph Todisco: Yes, look, right now the size and scope of the pilot, we've shifted 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, right, that LDO kind of over the hump and to the point of commercialization. So we're taking that 1 day by day. On the REZZAYO prophy, the full data set is not yet out, so we really haven't been able to conduct a 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 1 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. Operator: Our next question comes from Serge Belanger with Needham & Company. Serge Belanger: I guess first on the new LDO, first, congratulations. It's just a pilot program. I guess my question is why did the LDO decide to enter an agreement now when the product has been available for 2 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 III trial was conducted in allogeneic HSCT patients. Curious if you'll be able to address the broad patient population that could benefit from REZZAYO. Joseph Todisco: 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 now, right, 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, we don't -- just coming out of the pre-NDA meeting, we don't have yet visibility of what the final label will be. Operator: Our next question comes from Brandon Folkes with H.C. Wainwright. Brandon Folkes: Congrats on the progress. Maybe just 1 from me. Can you just talk about the SG&A in the quarter and the updated guidance? Did you take any actions in the quarter, whether it's -- especially on the sales and marketing infrastructure, right, just on DefenCath or the existing Melinta portfolio, just any color there on the expense discipline on the SG&A line. Thank you. Joseph Todisco: 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 or is coming in later in the year. But... Susan Blum: Yes. 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 reported in the second quarter. So it essentially eliminated 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: It does. And then just to confirm, so, there's been no actions taken on the DefenCath sales and marketing infrastructure ahead of sort of the lower reimbursement? Susan Blum: No, there have been no actions taken in the company. Brandon Folkes: Perfect. Congrats on the progress. Operator: This concludes our question and answer session. Thank you for attending today's presentation. You may now disconnect. 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CorMedix Therapeutics CRMD delivered second-quarter 2026 adjusted earnings of 29 cents per share, which increased 4% year over year from 28 cents reported in the year-ago quarter. The reported figure beat the Zacks Consensus Estimate of 26 cents. Consolidated revenues were $101.9 million, which rose 157% from $39.7 million a year ago and came above the Zacks Consensus Estimate of $95 million. Results reflected continued DefenCath utilization among large outpatient dialysis customers and a full-quarter contribution from the acquired Melinta portfolio. Management also lifted its full-year EBITDA outlook following the better-than-expected second-quarter 2026 results. The stock gained 14.7% on Thursday following the earnings release. DefenCath remained the largest revenue source in the quarter, generating $66.1 million in sales. Management said continued utilization by large outpatient dialysis customers supported performance, while the year-over-year increase was driven largely by the onboarding of a large dialysis organization in mid-2025. CorMedix also signed a multi-year commercial supply agreement for DefenCath with another large dialysis organization, bringing its commercial supply agreements to all five of the top U.S. dialysis providers. The customer placed an initial order and is set to begin a pilot in the third quarter, giving CRMD another potential avenue for broader DefenCath utilization. The acquired Melinta portfolio contributed $35.8 million to second-quarter revenues. The Melinta acquisition closed in August 2025, so the second quarter of 2025 included revenues only from DefenCath, making the year-over-year revenue comparison structurally different. Shares of CorMedix have plunged 30% so far this year against the industry’s 5.8% growth. Image Source: Zacks Investment Research Total operating expenses were $34.2 million in the second quarter, up about 87% from $18.3 million a year earlier. The increase mainly reflected a full quarter of expenses from the Melinta acquisition and the combined company's larger cost structure. R&D expenses rose significantly to $6.7 million from $2.4 million, driven primarily by higher personnel and clinical study services supporting ongoing programs. Selling and marketing expenses increased about 95% to $12.4 million, while general and administrative expenses rose about 59% to $15.1 million. CorMedix ended the second quarter with cash and cash equivalents of $256.7 million, excluding restricted cash, up from $178.1 million at the end of the first quarter of 2026. Management believes its existing resources are sufficient to fund operations for at least 12 months from the issuance of the company’s second-quarter Form 10-Q. Management maintained its full-year 2026 consolidated revenue guidance of $325-$345 million. It also reiterated DefenCath's revenue guidance of $175-$195 million, with management noting that the franchise was tracking toward the middle to upper end of that range. CorMedix raised its full-year adjusted EBITDA guidance to $125-$140 million. Management also said recent customer contract amendments covering third- and fourth-quarter 2026 pricing, and in some cases 2027 pricing and volume commitments, improved visibility into utilization through year-end. CorMedix Inc price-consensus-eps-surprise-chart | CorMedix Inc Quote CorMedix, with partner Mundipharma, expects to submit a supplemental new drug application for Rezzayo in prophylaxis of invasive fungal disease in the third quarter of 2026. The phase III ReSPECT study of the drug met its primary FDA endpoint of fungal-free survival at day 90 and demonstrated non-inferiority versus the standard antifungal regimen. If the filing is accepted for review, the company expects FDA action in the first half of 2027. CorMedix is also advancing its phase III DefenCath study in patients with total parenteral nutrition, having submitted a protocol amendment to narrow certain exclusion criteria. The company continues to expect study completion in 2028. CorMedix currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Amneal Pharmaceuticals AMRX, Repligen RGEN and AC Immune ACIU. AMRX and RGEN currently sport a Zacks Rank #1 (Strong Buy) each, while ACIU carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, earnings estimates increased from $1.12 to $1.21 for 2027. AMRX shares have risen 37% year to date. Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62. RGEN shares have lost 2.2% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have plunged 18.2% year to date. AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report CorMedix Inc (CRMD) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report AC Immune (ACIU) : Free Stock Analysis Report AMNEAL PHARMACEUTICALS, INC. (AMRX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Secured a multi-year commercial supply agreement with the final remaining top-5 large dialysis organization (LDO), achieving full coverage of the leading U.S. dialysis providers. Maintained stable DefenCath utilization through the initial post-TDAPA reimbursement transition, with July order volumes aligning with management's internal forecasts. Implemented contract amendments with major customers to provide pricing and volume visibility through year-end 2026 and into 2027, aimed at ensuring patient therapy continuity. Advanced the REZZAYO pipeline following positive Phase III ReSPECT data, which demonstrated non-inferiority to standard antifungal regimens in preventing invasive fungal disease. Leveraged the Melinta portfolio acquisition to drive significant year-over-year revenue growth and establish a diversified, cash-generative business model. Focused internal resources on Medicare Advantage contracting, viewing it as a critical long-term growth lever despite lengthy negotiation cycles. Utilized a growing body of real-world evidence to validate DefenCath's clinical value proposition, specifically regarding reductions in hospitalizations and tPA usage. Anticipate submission of the REZZAYO sNDA for prophylaxis in Q3 2026, with potential FDA action expected in the first half of 2027. Raised full-year 2026 adjusted EBITDA guidance to $125-$140 million, reflecting disciplined capital allocation and operational efficiencies. Planning a strategic commercial scale-up for REZZAYO in the second half of 2026, including 15 to 20 new positions to prepare for a potential 2027 launch. Expect to complete the Phase III TPN study in 2028, supported by protocol amendments designed to accelerate patient enrollment. Monitoring the final ESRD rule expected in November 2026 to adjust commercial strategies based on the finalized Medicare reimbursement framework. Recorded a $4.2 million G&A expense reduction in Q2 2026 due to insurance reimbursement for legal fees related to ongoing securities litigation. Acknowledged expected attrition among smaller dialysis providers following the TDAPA expiration, while larger accounts remain stable. Noted that 2026 guidance excludes potential contributions from Medicare Advantage contracts due to the uncertainty of timing. Highlighted that ownership of the REZZAYO U.S. NDA will transfer from Mundipharma to CorMedix only upon FDA approval of the prophylaxis indication. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management stated the new LDO pilot involves a couple hundred clinics and is currently reflected within existing 2026 guidance. Specific 2027 guidance will not be provided until late 2026 or early 2027, pending visibility into pilot adoption and Medicare Advantage progress. Management identified two primary levers for future volume growth: meaningful adoption by the new LDO and successful Medicare Advantage contracting. Current volumes are described as stabilized with large players, offsetting anticipated attrition among smaller facilities. Management noted that robust market research is pending the publication of full Phase III data in Q4 2026. The final scope of the label for prophylaxis will be determined during the FDA review process following the Q3 sNDA submission. Management confirmed no reductions were made to the DefenCath sales and marketing infrastructure despite the reimbursement transition. The Q2 G&A expense was 'artificially low' due to a $4.2 million litigation-related insurance credit, $2.7 million of which related to prior periods.

‒ Q2 2026 Consolidated Revenue of $101.9 million ‒ ‒ Q2 2026 Net Income of $26.0 million; Adjusted EBITDA of $58.7 million ‒ ‒ Company Maintains FY 2026 Revenue and Raises Adjusted EBITDA Guidance ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ PARSIPPANY, N.J., Aug. 13, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD) today announced financial results for the second quarter ended June 30, 2026, and provided an update on its business. Recent Corporate Highlights: CorMedix announces $101.9 million of total revenue and grant income (“consolidated revenue”) for the second quarter of 2026, reflecting strong second quarter execution and positive underlying demand trends. The Company also recognized net income of $26.0 million and adjusted EBITDA of $58.7 million (1). Basic and fully diluted EPS were $0.33 and $0.29 per share, respectively, for the quarter. DefenCath® (taurolidine and heparin) sales contributed $66.1 million of net revenue in the second quarter, driven by continued utilization of DefenCath by large outpatient dialysis customers. The acquired Melinta portfolio contributed $35.8 million. CorMedix announced today that in collaboration with our global development partner Mundipharma, the company anticipates FDA submission of the sNDA for an expanded indication of REZZAYO for the prophylaxis of invasive fungal disease in the third quarter of this year. Provided the application is accepted for FDA review, the Company anticipates agency action on the application in H1 2027. The Company signed a new multi-year commercial supply agreement for DefenCath® with a Large Dialysis Operator (LDO), expanding the company’s commercial contract footprint to include all of the top 5 providers of dialysis services in the U.S. market. The LDO has commenced ordering of DefenCath® and will begin a pilot in the third quarter this year. The Company maintains full-year 2026 consolidated revenue guidance of $325 to $345 million, and raises full-year adjusted EBITDA guidance to a range of $125 to $140 million. Cash OpEx guidance is narrowed to a range of $145 to $155 million. Cash and short-term investments, excluding restricted cash, at June 30, 2026 totaled $256.7 million. Joseph Todisco, CorMedix Chairman & CEO, commented, “CorMedix delivered a strong second quarter, generating $101.9 million in consolidated revenue and $58.7 million of adjusted EBITDA, reflecting continued execution across our business. We remain confident in our full-year 2026 outlook and our revenue and adjusted EBITDA guidance as we continue to navigate the post-TDAPA reimbursement environment for DefenCath with discipline and focus. We also made meaningful progress across our pipeline and expect the near-term submission of the REZZAYO sNDA for prophylaxis. With a strong balance sheet, meaningful cash position, and a disciplined capital allocation strategy, we believe CorMedix is well positioned to support our commercial priorities, advance high-value development programs, and create sustainable long-term value for shareholders." (1)   Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items.  See “Non-GAAP Financial Measures” on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure. Second Quarter 2026 Financial Highlights For the second quarter of 2026, CorMedix recorded $101.9 million in consolidated revenue, comprised of $66.1 million in sales of DefenCath and $35.8 million associated with the acquired Melinta portfolio, an increase from $39.7 million in total revenue in the comparable period of 2025. DefenCath sales increased year over year largely due to the onboarding of a large dialysis organization in mid-2025. As the Melinta acquisition occurred in August 2025, the second quarter of 2025 included revenue from only sales of DefenCath. Total operating expenses in the second quarter of 2026 were $34.2 million, 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 period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter and reflects the larger combined company. Research and development (R&D) expenses in the second quarter of 2026 were $6.7 million, compared with $2.4 million for the same period in 2025. The increase in R&D was primarily due to an increase in personnel and clinical trial services in support of the ongoing clinical programs, including pediatric studies for several brands and the 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 primarily due to higher personnel cost associated with the 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 primarily attributable to 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. This year-over-year increase in G&A was partially offset by the recognition of $4.2 million during the three months ended June 30, 2026, 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. 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 the second quarter of 2025. Also for the second quarter of 2026, CorMedix reported adjusted EBITDA of $58.7 million, compared to adjusted EBITDA of $22.4 million in the second quarter of 2025. The Company reported cash and cash equivalents of $256.7 million at June 30, 2026, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q. Conference Call Information CorMedix will host a conference call and webcast today, August 13, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: August 13, 2026 @ 8:30am ETDomestic: 1-844-676-2922 International: 1-412-634-6840Webcast: Webcast Link About CorMedix CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. For more information visit: www.cormedix.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial and business guidance; sales, revenue and operating expense estimates; Adjusted EBITDA estimates; expectations regarding product utilization and sales; the risk that topline data from CorMedix’s and its partners’ clinical trials, including the ReSPECT study, that CorMedix announces or publishes from time to time may change as more patient data become available or may be interpreted differently if additional data is disclosed; estimates of total addressable market size; failure to successfully conduct future clinical trials, including due to CorMedix’s or its partners’ potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to CorMedix’s product candidates; expectations and timing regarding clinical trials and development, performance expectations and revenue opportunities of CorMedix’s product pipeline; expectations regarding implementation and perceived benefits of CorMedix’s products; continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals and reporting obligations related thereto; the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. In addition, pro forma financial information does not necessarily reflect the actual results that we would have achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of the combined company. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including EBITDA and adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results, which facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management. These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business. Investor Contact:Dan FerryManaging DirectorLifeSci [email protected](617) 430-7576

CorMedix (CRMD) came out with quarterly earnings of $0.29 per share, beating the Zacks Consensus Estimate of $0.26 per share. This compares to earnings of $0.28 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +11.54%. A quarter ago, it was expected that this pharmaceutical and medical device company would post earnings of $0.35 per share when it actually produced earnings of $0.43, delivering a surprise of +22.86%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. CorMedix, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $101.93 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 7.64%. This compares to year-ago revenues of $39.74 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. CorMedix shares have lost about 39% since the beginning of the year versus the S&P 500's gain of 13.2%. While CorMedix has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for CorMedix was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.08 on $53.9 million in revenues for the coming quarter and $0.51 on $335.4 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. AnaptysBio, Inc. (ANAB), another stock in the same industry, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.22 per share in its upcoming report, which represents a year-over-year change of +83.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. AnaptysBio, Inc.'s revenues are expected to be $27.4 million, up 23.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report CorMedix Inc (CRMD) : Free Stock Analysis Report AnaptysBio, Inc. (ANAB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Revenue: Second quarter 2026 consolidated revenue was $101.9 million, compared with $39.7 million in the second quarter of 2025. DefenCath Revenue: Sales of DefenCath were $66.1 million in the second quarter. Melinta Portfolio Revenue: Revenue associated with the acquired Melinta portfolio was $35.8 million in the second quarter. Operating Expenses: Total 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%. Research and Development Expenses: R&D expenses were $6.7 million in the second quarter of 2026, compared with $2.4 million in the same period of 2025. Sales and Marketing Expenses: Sales and marketing expenses increased approximately 95% to $12.4 million in the second quarter of 2026 from $6.4 million in the second quarter of 2025. General and Administrative Expenses: G&A expenses increased approximately 59% to $15.1 million in the second quarter of 2026 from $9.5 million in the second quarter of 2025. Net Income: 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 the second quarter of 2025. Adjusted EBITDA: Adjusted EBITDA was $58.7 million for the second quarter of 2026, compared with $22.4 million in the second quarter of 2025. Cash and Cash Equivalents: The company ended the second quarter with $256.7 million in cash and cash equivalents. Cash Flow from Operations: For the first 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. Full-Year 2026 Revenue Guidance: Reaffirmed full-year 2026 consolidated revenue guidance of $325 million to $345 million. Full-Year 2026 DefenCath Revenue Guidance: Full-year DefenCath revenue guidance of $175 million to $195 million. Full-Year 2026 Adjusted EBITDA Guidance: Raised full-year adjusted EBITDA guidance to a new range of $125 million to $140 million. Warning! GuruFocus has detected 6 Warning Signs with CRMD. Is CRMD fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Signed a multi-year commercial supply agreement with an additional large dialysis organization, now covering all top 5 US dialysis providers, with a pilot starting in Q3 2026 and potential expansion in 2027. Reaffirmed full-year 2026 revenue guidance of $325-$345 million and raised adjusted EBITDA guidance to $125-$140 million, reflecting strong financial performance. Reported strong Q2 2026 results with consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million, driven by DefenCath sales and the Melinta portfolio. Positive Phase 3 ReSPECT data for Rezzayo in prophylaxis of invasive fungal disease, with sNDA submission planned for Q3 2026 and potential FDA action in H1 2027. Strong cash position of $256.7 million and significant cash generation ($128.6 million from operations in H1 2026), enabling reinvestment in growth and pipeline development. DefenCath order volumes in July tracked consistent with post-TDAPA forecasts, and contract amendments with major customers provide improved pricing and volume visibility through 2027. Progress in Medicare Advantage contracting, which represents a meaningful long-term growth opportunity, though not included in 2026 guidance. Growing real-world evidence supporting DefenCath's clinical and economic value, with additional data presentations expected at ASN and IDWeek in Q4 2026. The newly signed LDO agreement is only a pilot program, with no guaranteed expansion, and its contribution to 2027 revenue is uncertain. The post-TDAPA environment has led to some attrition among smaller dialysis providers, which could impact future volumes. Medicare Advantage contracting cycles are lengthy, and no contribution from this channel is assumed in 2026 guidance, limiting near-term growth. The Rezzayo sNDA submission is dependent on partner Mundipharma, and FDA approval timelines are uncertain, with potential delays. Operating expenses increased significantly (87% year-over-year) due to the Melinta acquisition, and cash OPEX guidance was narrowed to $145-$155 million, reflecting higher costs. The final ESRD rule for reimbursement is still uncertain, and the proposed rule differs from expectations, creating potential headwinds for DefenCath pricing. The full Rezzayo data set has not yet been published, limiting market research and prescriber feedback, which could affect commercial readiness. Q: How is the new multi-year agreement with the additional large dialysis organization (LDO) expected to impact 2027 expectations, and how long does it take for a new site to reach steady-state production?A: Joseph Todisco, Chairman and CEO, stated that the agreement was recently signed and the LDO is rolling out a pilot. The company is waiting to see the results and will not comment on 2027 guidance until late this year or early next year due to many variables. He noted that the pilot's revenue is included in the current 2026 guidance, and DefenCath is currently tracking to the mid-to-top part of its guidance range. Q: Can you comment on volume growth in existing channels during the post-TDAPA period, and how are you thinking about future growth levers?A: Joseph Todisco, Chairman and CEO, explained that July volumes have stabilized with larger players, with some expected attrition among smaller players. He highlighted Medicare Advantage contracting as a key growth lever, noting cautious optimism about having something in place that could take effect early next year. He also mentioned the proposed ESRD rule, which differed from expectations regarding the quarterly mechanism, and expects significant commentary before the final rule is issued. Q: Can you provide more color on the size or scope of the pilot study with the new LDO, and what feedback are you getting from potential prescribers on the Rezzayo Phase 3 data?A: Joseph Todisco, Chairman and CEO, said the pilot involves an initial order covering a couple hundred clinics, but declined to provide more details. For Rezzayo, he noted that the full data set has not yet been published, so robust market research has not been conducted. The data is expected to be presented at medical conferences in the fourth quarter, after which the company can better assess prescriber feedback. Q: Why did the new LDO decide to enter an agreement now, and what are your expectations for the potential labeling of Rezzayo following the FDA meeting?A: Joseph Todisco, Chairman and CEO, said he cannot speak to the LDO's motivations but noted the company has built a wealth of real-world evidence supporting DefenCath's clinical and pharmacoeconomic benefits. Regarding Rezzayo, he stated that labeling is a review issue, and the company does not yet have visibility into the final label as it works through the process following the pre-NDA meeting. Q: Can you discuss the SG&A in the quarter and the updated guidance, including any actions taken on expense discipline?A: Joseph Todisco, Chairman and CEO, said no deliberate actions were taken, with expenses trending slightly light as some staffing comes on later in the year. Susan Blum, CFO, added that G&A was reduced by $4.2 million due to expected insurance reimbursement of legal fees related to securities litigation, with $2.7 million of that credit relating to prior periods. She noted the run rate would be $2.7 million higher without that reversal. Q: What were the key financial results for the second quarter of 2026?A: Susan Blum, CFO, reported consolidated revenue of $101.9 million, including $66.1 million in DefenCath sales and $35.8 million from the acquired Melinta portfolio. Operating expenses were $34.2 million, and the company recorded net income of $26.0 million, or $0.33 per basic share. Adjusted EBITDA was $58.7 million, and the company ended the quarter with $256.7 million in cash and cash equivalents. Q: What is the company's financial guidance for the full year 2026?A: Joseph Todisco, Chairman and CEO, reaffirmed full-year 2026 consolidated revenue guidance of $325 million to $345 million and DefenCath revenue guidance of $175 million to $195 million. The company raised its full-year adjusted EBITDA guidance to $125 million to $140 million. Cash OPEX guidance was narrowed to $145 million to $155 million, excluding non-cash charges. Q: What are the key updates on the Rezzayo prophylaxis program and the DefenCath TPN study?A: Elizabeth Masson-Hurlburt, COO, stated that the ReSPECT study met its primary endpoint of fungal-free survival at day 90, showing non-inferiority versus standard antifungal regimens. The company is working with Mundipharma on the sNDA submission in the third quarter, with additional data expected at medical conferences in Q4. For the TPN study, a protocol amendment was submitted to FDA to narrow exclusion criteria and support increased enrollment, with study completion expected in 2028. Q: What real-world evidence updates are expected for DefenCath?A: Elizabeth Masson-Hurlburt, COO, said multiple abstracts have been submitted to ASN and IDWeek for the fourth quarter. These will present final results from the US Renal Care real-world evidence study, showing a meaningful impact on infection-related hospitalizations and catheter-related bloodstream infections, as well as two external studies highlighting DefenCath's efficacy with chlorhexidine caps and its clinical and economic benefits in reducing tPA use. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in CorMedix Inc? Here are five stocks we like better. CorMedix reported strong second-quarter results with revenue of $101.9 million, adjusted EBITDA of $58.7 million and net income of $26.0 million. The company reaffirmed 2026 revenue guidance of $325 million-$345 million and raised adjusted EBITDA guidance to $125 million-$140 million. The company signed a multiyear DefenCath supply agreement with the fifth-largest U.S. dialysis provider, giving it contracts with all five major dialysis organizations. A pilot is expected to begin in the third quarter, while Medicare Advantage adoption and additional real-world evidence could support future growth. CorMedix expects Mundipharma to file a supplemental application for REZZAYO in the third quarter, following positive Phase III results, with potential FDA action in the first half of 2027. The company is also continuing its Phase III DefenCath total parenteral nutrition study, which remains on track for completion in 2028. High Risk, High Reward: 3 Healthcare Stocks to Watch in 2026 CorMedix (NASDAQ:CRMD) reported second-quarter 2026 consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million, while reaffirming its full-year revenue outlook and raising adjusted EBITDA guidance. The company also said it signed a multiyear commercial supply agreement for DefenCath with an additional large dialysis organization, giving it supply agreements with each of the five largest U.S. dialysis providers. Chairman and Chief Executive Officer Joseph Todisco said the newly signed dialysis organization has placed an initial order and is expected to begin a DefenCath pilot during the third quarter. The pilot could expand in 2027, though management said it was too early to provide detailed expectations for next year. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Why CorMedix Could be the Biopharma Name to Watch Early in 2026 “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,” Todisco said. CorMedix said DefenCath order volumes in July were consistent with pricing under the 2026 post-TDAPA reimbursement environment. In some cases, the company said it has pricing and volume commitments extending into 2027, intended to help keep patients on therapy during the reimbursement transition. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand MarketBeat’s Top 5 Rated Small-Cap Stocks Todisco told analysts that July volumes had stabilized among larger dialysis providers, while the company had seen some expected attrition among smaller providers. He said meaningful DefenCath volume growth could come from adoption by the newly contracted dialysis organization or through Medicare Advantage contracting. The company said it is continuing to devote resources to Medicare Advantage discussions, but it has not included any contribution from Medicare Advantage in its 2026 guidance. Todisco said the contracting process can take time, though management is cautiously optimistic that agreements could begin to affect volumes early next year. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Management also said it expects additional real-world evidence related to DefenCath to be presented during the fourth quarter, assuming submitted abstracts are accepted by the American Society of Nephrology's Kidney Week and IDWeek. Liz Hurlburt, CorMedix's chief operating and commercial officer, said the expected presentations include data on catheter-related bloodstream infections, the use of DefenCath with chlorhexidine antimicrobial caps, and clinical and economic outcomes related to reduced tPA use in outpatient hemodialysis facilities. Revenue for the quarter rose from $39.7 million in the second quarter of 2025. The 2026 total included $66.1 million in DefenCath sales and $35.8 million from the acquired Melinta portfolio. Chief Financial Officer Susan Blum noted that year-over-year comparisons reflect the inclusion of a full quarter of Melinta operations in 2026, while the acquisition had not yet closed during the comparable period a year earlier. Operating expenses were $34.2 million, compared with $18.3 million a year earlier. Research and development expense was $6.7 million, up from $2.4 million. Selling and marketing expense increased to $12.4 million from $6.4 million. General and administrative expense increased to $15.1 million from $9.5 million. Net income was $26.0 million, or $0.33 per basic share and $0.29 per diluted share, compared with $19.8 million a year earlier. The company ended the quarter with $256.7 million in cash and cash equivalents. Blum said second-quarter general and administrative expense included $4.2 million in insurance reimbursements related to legal fees, including $2.7 million associated with costs incurred in prior periods. She said the reimbursement made the reported expense level appear lower than the underlying run rate. CorMedix reaffirmed full-year 2026 consolidated revenue guidance of $325 million to $345 million, including DefenCath revenue of $175 million to $195 million. The company raised its adjusted EBITDA outlook to $125 million to $140 million. It also narrowed cash operating expense guidance to $145 million to $155 million. CorMedix said it expects its partner, Mundipharma, to submit a supplemental new drug application during the third quarter for REZZAYO as prophylaxis for invasive fungal disease in adult immunosuppressed patients undergoing allogeneic bone and marrow transplant. The planned filing follows preliminary top-line results from the Phase III ReSPECT trial, which met its primary endpoint of fungal-free survival at day 90 by demonstrating non-inferiority to the standard antifungal regimen. Hurlburt said the study also showed a favorable profile across secondary endpoints, including treatment-emergent adverse events that led to dose reduction, interruption or withdrawal of study drugs, and study discontinuation. CorMedix said that, assuming a timely submission and FDA acceptance, it anticipates potential agency action in the first half of 2027. The company expects to add 15 to 20 commercial and medical positions during the second half of 2026 as it prepares for a potential launch. Those planned investments are included in its cash operating expense outlook. Management said detailed ReSPECT data are expected to be presented at one or more medical conferences in the fourth quarter. Todisco said the company has not yet conducted robust market research with potential prescribers because the full data set has not been released. CorMedix also provided an update on its Phase III study of DefenCath in total parenteral nutrition. Hurlburt said the company submitted a protocol amendment to the FDA that narrows certain exclusion criteria and has activated additional trial sites. The company continues to expect completion of the study in 2028. Todisco said CorMedix generated $277.8 million of adjusted EBITDA over the trailing 12 months and had $267 million of combined cash and investments at quarter-end, positioning the company to fund pipeline development and pursue business-development opportunities. CorMedix Inc is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to reduce inflammation and prevent infection in critically and chronically ill patient populations. The company's lead product candidate, Neutrolin, is a catheter lock solution that combines taurolidine, heparin and citrate to prevent catheter-related bloodstream infections (CRBSIs) in patients undergoing hemodialysis. Neutrolin has received market authorization in the European Union under the CE Mark and is positioned to address a significant unmet medical need for infection prevention in dialysis centers. In addition to its lead asset, CorMedix is advancing a biochemical portfolio aimed at mitigating complications associated with peritoneal dialysis and other high-risk procedures. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "CorMedix Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

CorMedix reported Q2 revenue of $101.9 million, above Wall Street’s estimate of about $96.05 million, according to Fiscal.ai. The firm raised its adjusted earnings before interest, tax, depreciation and amortization guidance to between $125 million and $140 million. CorMedix signed a multi-year DefenCath catheter lock solution supply agreement with an unnamed major dialysis operator Shares of CorMedix Therapeutics (CRMD) surged 17% on Thursday after the company reported better-than-expected second-quarter results and said it plans to seek an expanded indication with the U.S. Food and Drug Administration for its antifungal treatment. CRMD stock clocked its biggest single-day gains since October 2025 and also hit the crucial 200-day moving average (200-DMA) for the first time in over a month. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox CorMedix reported second-quarter (Q2) revenue of $101.9 million, up sharply from $39.7 million a year earlier and above Wall Street’s estimate of about $96.05 million, according to Fiscal.ai. Diluted earnings came in at $0.29 per share, topping analysts’ estimate of $0.24 per share. CorMedix also said it expects to submit the supplemental application to the Food and Drug Administration (FDA) for Rezzayo in the third quarter. If accepted for review, an FDA decision is expected in the first half of 2027. The proposed indication would expand Rezzayo’s use to the prevention of invasive fungal disease. “We also made meaningful progress across our pipeline and expect the near-term submission of the Rezzayo sNDA for prophylaxis,” said CEO Joseph Todisco. CorMedix also signed a multi-year DefenCath catheter lock solution supply agreement with an unnamed major dialysis operator. CorMedix raised its adjusted earnings before interest, tax, depreciation and amortization (EBITDA) guidance to between $125 million and $140 million, from $115 million to $135 million previously. The company maintained its 2026 revenue guidance of $325 million to $345 million. CorMedix ended June with $256.7 million in cash and short-term investments, which it believes is sufficient to fund operations for at least the next 12 months. During the quarter, CorMedix’s unit Melinta Therapeutics secured a key legal win after a U.S. appeals court upheld a ruling in favor of Melinta in its patent dispute with Nexus Pharmaceuticals. The court found that Nexus’ proposed generic antibiotic infringed patents covering Minocin for injection and rejected its challenge to their validity. Nexus remains barred from selling the generic until the patents expire. Minocin is an intravenous antibiotic used to treat serious and drug-resistant infections. Retail sentiment surrounding CRMD on Stocktwits flipped to ‘extremely bullish’ from ‘neutral’ a day earlier, amid a 140% jump in message volumes. One bullish user said the next few days could be crazy. The stock is down nearly 32% year-to-date. Also read: Intuitive Machines Posted Record Q2 Revenue – So, Why Is LUNR Stock Declining Today? For updates and corrections, email newsroom[at]stocktwits[dot]com. Arnab Paul has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: Why Did PANW, NET, HPQ Stocks Jump To 52-Week Highs Today? SLS And IBRX Eye Green Weekly Close: Vanguard’s Major Stakes In Cancer Drugmakers Steal The Spotlight RKLB Stock Gains Overnight: Rocket Lab Advances Neutron’s ‘Hungry Hippo’ And Wins New Space Force Deal