Q2 2026 CorMedix Inc Earnings Call Transcript
Key Points
- 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.
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.
Good morning, and welcome to the CorMedix Second Quarter 2026 Earnings and Corporate Update Conference Call. Leading the call today is Joseph Todisco, Chairman and Chief Executive Officer of CorMedix. We're joined by Elizabeth Masson-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
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