CorMedix Inc. 2026 Q2 Earnings Call

Please go ahead. Good morning, and welcome to the CorMedix second quarter 2026 earnings.

VP 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 of the company's prospects and future financial position. Actual results may differ materially from the estimates and projections on which these. 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. It's my pleasure to turn the call over to Joseph Todisco, Chairman and Chief Executive Officer of CorMedix. Joe, please go ahead. 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. Lastly, deploying our capital in a disciplined manner to 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 five 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 POTR 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 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 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 Commercial Officer, Liz Hurlburt, to provide an update on clinical activities.

Liz, please go ahead. 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. Following a constructive pre-NDA meeting with the FDA, we 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 the treatment of 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 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 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 some in catheter-related bloodstream infections, as well as two other external studies. The first will highlight the demonstrated efficacy of DefenCath when used in combination with chlorhexidine antimicrobial caps. 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.