Key Highlights

  • Revenue of $101.9 million beat the $96 million estimate by 6.13 percent, while adjusted EPS of $0.29 beat the $0.26 estimate by 11.54 percent.
  • The company signed a new multi-year commercial Supply agreement with an additional large dialysis organization, giving CorMedix agreements with all five top dialysis providers in the U.S.
  • The company reaffirmed full-year 2026 Revenue guidance of $325 million to $345 million and raised full-year adjusted EBITDA guidance to $125 million to $140 million.
  • REZZAYO's Phase 3 ReSPECT study met its primary endpoint for fungal-free survival, with the company anticipating submission of a supplemental new drug application for the prophylaxis indication in the third quarter.

Fifth Major Dialysis Provider Agreement Validates DefenCath's Clinical Case

CorMedix Inc (NASDAQ:CRMD), a biopharmaceutical company commercializing DefenCath, an antimicrobial catheter lock solution for hemodialysis patients, reported second-quarter revenue of $101.9 million, including $66.1 million from DefenCath and $35.8 million from its acquired Melinta antibiotics portfolio. The quarter's most significant development was a new multi-year commercial supply agreement with an additional large dialysis organization, giving the company agreements in place with all five of the largest dialysis providers in the U.S., with the new partner beginning a pilot program in the third quarter and potential for expanded utilization in 2027.

Management characterized the agreement as an important validation of DefenCath's clinical value proposition given the scale of the customer, though executives declined to quantify the pilot's expected size beyond describing initial shipments covering a couple hundred clinics. The company said it is not assuming meaningful additional revenue contribution from this new agreement within current 2026 guidance, positioning any incremental uptake as potential upside rather than a baked-in growth driver.

Order Volumes Stabilize as Reimbursement Transition Progresses

Management said DefenCath order volumes in July tracked consistent with expected 2026 pricing and, in some cases, included pricing and Volume commitments extending into 2027, describing July trends as showing stabilized volumes among larger dialysis customers alongside expected attrition among smaller providers as the post-TDAPA reimbursement transition continues. Executives said meaningful DefenCath volume growth from here will likely depend on either the newly signed dialysis organization ramping meaningfully or progress in ongoing Medicare Advantage contracting discussions, with the company continuing to expect the latter could begin contributing as early as next year.

The company noted that a proposed CMS rule for the End Stage Renal Disease program differed somewhat from expectations regarding its quarterly payment mechanism, with management anticipating significant public comment before a final rule is issued in November, at which point the company will adjust its outlook accordingly. Real-world evidence supporting DefenCath's clinical and pharmacoeconomic value continues to expand, with additional data presentations expected this fall at the American Society of Nephrology's Kidney Week and IDWeek conferences.

REZZAYO Pipeline Advances Toward a Potential 2027 Approval

The company's Phase 3 ReSPECT study for REZZAYO in the prophylaxis of invasive fungal disease met its primary endpoint of non-inferiority for fungal-free survival at day 90 compared with standard antifungal treatment, with favorable results across multiple secondary endpoints related to treatment-related adverse events. Following a constructive pre-submission meeting with the FDA, the company expects its partner Mundipharma to submit a supplemental new drug application in the third quarter, with potential agency action anticipated in the first half of 2027 assuming timely filing and acceptance.

Ahead of a potential launch, the company plans to add 15 to 20 commercial and medical positions in the back half of the year, spending already reflected within its narrowed full-year cash Operating Expense guidance of $145 million to $155 million. Separately, the company submitted a protocol amendment narrowing exclusion criteria for its ongoing Phase 3 trial evaluating DefenCath in total parenteral nutrition patients, aiming to support increased enrollment, with study completion still expected in 2028.

Raised Profitability Guidance Reflects Confidence Despite Reimbursement Uncertainty

CorMedix reaffirmed full-year 2026 revenue guidance of $325 million to $345 million, including DefenCath-specific revenue guidance of $175 million to $195 million, while raising full-year adjusted EBITDA guidance to $125 million to $140 million from a prior range, reflecting confidence in underlying Business execution even as post-TDAPA ordering patterns continue to evolve. The company reported trailing 12-month adjusted EBITDA of $277.8 million and ended the quarter with $256.7 million in cash and investments, providing flexibility to continue investing in the REZZAYO launch preparation and pipeline development. The primary swing factors for the remainder of the year are likely to be how quickly the newly signed dialysis organization's pilot program scales, progress in Medicare Advantage contracting discussions that remain excluded from current guidance, and the final CMS rule for dialysis reimbursement expected in November, which management said it will incorporate into its outlook once published.