CorMedix (NASDAQ: CRMD) presented its commercial momentum and pipeline outlook Wednesday at Wells Fargo’s 21st Annual Healthcare Conference, highlighting nearly $130 million in free cash flow generated in the first six months of the year and a growing product portfolio anchored by its acquisition of Melinta Biotech.
Joseph Todisco, CorMedix chairman and CEO, said the company now operates eight marketed products distributed across more than 500 hospitals, infusion centers and clinics, with supply agreements covering all five of the largest dialysis providers in the United States.
Gross profit margin stood at 90%, and return on assets reached 32%, Todisco said. Cash on hand exceeded $300 million, up from $260 million at the end of the second quarter, while adjusted EBITDA over the trailing 12 months was approximately $275 million. Earlier this year the company authorized $75 million in share repurchases.
The Melinta acquisition, completed around September 2025, gave CorMedix a base of institutional anti-infective drugs, notably Vabomere and Minocin, which Todisco called “major revenue drivers.” He also pointed to Kimyrsa, a long-acting anti-infective positioned for a relaunch, and Baxdela, a broad-spectrum antibiotic partnered with BARDA in a biodefense program.
A central focus of the presentation was REZZAYO, CorMedix’s antifungal drug acquired with Melinta, which is currently approved for treatment but seeking a prophylactic indication. The company targets submission of a supplemental new drug application in the third quarter, with a full data set expected in Q4 and publication at medical meetings. Todisco said the goal is FDA approval in the first half of 2027, with launch preparation beginning in the second half of that year.
Management estimated the addressable market for the studied patient population — hematological malignancy patients receiving bone marrow transplants — at $500 million, a figure that could expand roughly eightfold if the prophylactic indication is approved. Market research cited by the company suggested 15% to 20% of patients discontinue azole therapy due to toxicity or drug interactions.
CorMedix plans to add 15 to 20 commercial and medical roles to prepare for the REZZAYO launch, though Todisco said the typical field team can handle multiple products “in the bag.”
On DefenCath, the company’s core asset for preventing catheter-related bloodstream infections in dialysis care, Todisco noted the 24-month TDAPA separate payment period ended June 30, transitioning DefenCath into a bundled add-on phase effective July 1. A CMS ESRD final rule is expected in late November, potentially into December. Real-world evidence from a U.S. Renal Care study showed a 72% reduction in catheter-related bloodstream infections and a 70% reduction in related hospitalizations. Medicare Advantage patients account for an estimated 60% to 65% of the end-stage renal disease population.
DefenCath retains data exclusivity through 2032 and patent protection into the 2040s. REZZAYO’s patent coverage extends to 2038, while MINOCIN faces the shortest loss-of-exclusivity date at 2031.
Todisco also addressed Talphera, noting a Phase 3 data readout is expected in late 2024 or early 2025.
CorMedix shares were trading at $8.12 as of the conference, with analysts’ price targets ranging from $13 to $19. The company’s market capitalization was $633 million.
