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CorMedix Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 14 May 2026: press release. Guidance figures: 2 raised. The quarter’s numbers.

Key takeaways

  • Revenue rose to $127.4 million: Total revenue was $127.4 million, up from $39.1 million a year earlier. The year-earlier figure included DefenCath only, before the August 2025 Melinta acquisition. Source
  • Adjusted EBITDA reached $70.0 million: Adjusted EBITDA was $70.0 million, against $23.6 million a year earlier. Adjusted EBITDA is a non-GAAP measure that excludes depreciation, amortization, stock-based compensation and certain other items. Source
  • Full-year 2026 guidance was raised: Full-year 2026 net revenue and adjusted EBITDA guidance were both increased from the ranges given in the March release. Source
  • DefenCath sales reached $97.5 million: DefenCath net sales were $97.5 million in the quarter, bolstered by higher utilization from outpatient dialysis customers. Source
  • Operating expenses rose on Melinta: Total operating expenses were $41.5 million, up about 139% from $17.4 million, mainly from a full quarter of Melinta operating costs. Source
  • ReSPECT Phase III topline positive: The global ReSPECT Phase III trial of REZZAYO for prophylaxis in allogeneic stem cell transplant patients reported positive topline results on April 27, 2026. Source

“Lastly, we have delivered significant profitability and cash generation, allowing us to reinvest in growth, as well as shareholder value creation through stock repurchases, while preserving financial flexibility for new business development initiatives.”

Joseph Todisco, CorMedix Chairman & CEO

Guidance

AreaPeriodFigureAgainst last quarter
Net revenue SourceFull-year 2026$325 to $345 millionRaised from $300 to $320 million
Adjusted EBITDA SourceFull-year 2026$115 to $135 millionRaised from $100 to $125 million
TPN Phase 3 study completion SourceStudy completiontrending to completion in 2028

What changed from last quarter

  • Guidance raised: Full-year 2026 net revenue guidance was raised from $300 to $320 million to $325 to $345 million. Source
  • Guidance raised: Full-year 2026 adjusted EBITDA guidance was raised from $100 to $125 million to $115 to $135 million. Source
  • New: Positive Phase III topline results from the ReSPECT trial of REZZAYO for prophylaxis were announced on April 27, 2026. Source
  • New: New TPN study sites were opened and a protocol amendment was submitted to FDA. If approved, the amendment would remove certain exclusion criteria. Source

Results and growth drivers

  • Revenue rose to $127.4 million: Total revenue was $127.4 million, up from $39.1 million a year earlier. The year-earlier figure included DefenCath only, before the August 2025 Melinta acquisition. Source
  • Net income reached $38.6 million: Net income was $38.6 million, or $0.48 basic and $0.43 diluted EPS, compared with $20.6 million, or $0.32 and $0.30, a year earlier. Source
  • Adjusted EBITDA reached $70.0 million: Adjusted EBITDA was $70.0 million, against $23.6 million a year earlier. Adjusted EBITDA is a non-GAAP measure that excludes depreciation, amortization, stock-based compensation and certain other items. Source
  • Non-recurring $9.0 million sales allowance benefit: Quarter DefenCath sales included a non-recurring favorable change in estimate of $9.0 million for certain sales allowances. The company excluded this amount from adjusted EBITDA. Source
  • Full-year 2026 guidance was raised: Full-year 2026 net revenue and adjusted EBITDA guidance were both increased from the ranges given in the March release. Source

DefenCath and Melinta sales

  • DefenCath sales reached $97.5 million: DefenCath net sales were $97.5 million in the quarter, bolstered by higher utilization from outpatient dialysis customers. Source
  • Large dialysis onboarding drove growth: Year-over-year DefenCath growth was attributed largely to a large dialysis organization onboarded in mid-2025. Source
  • Melinta portfolio contributed $29.9 million: The acquired Melinta portfolio contributed $29.9 million, which management described as typical first-quarter purchasing for the anti-infective portfolio. Source
  • Anti-infective brands in the portfolio: The prior release listed the anti-infective brands in the Melinta portfolio, including MINOCIN, REZZAYO, VABOMERE and ORBACTIV, with BAXDELA, KIMYRSA and TOPROL-XL also named.

“we are advancing a pipeline of late-stage opportunities, including REZZAYO for prophylaxis, which we expect will meaningfully expand our long-term revenue opportunity”

Joseph Todisco, CorMedix Chairman & CEO

Operating expenses

  • Operating expenses rose on Melinta: Total operating expenses were $41.5 million, up about 139% from $17.4 million, mainly from a full quarter of Melinta operating costs. Source
  • G&A rose on combined-company costs: General and administrative expenses rose to $21.7 million, reflecting personnel, information technology, branded prescription drug, legal and facilities costs of the combined company. Source
  • Selling and marketing spend rose sharply: Selling and marketing expense rose about 180% to $12.5 million, on higher personnel costs for the larger product portfolio and related marketing programs. Source

Operating income, tax and other items

  • Operating income rose to $63.7 million: Income from operations was $63.7 million, up from $20.1 million, after cost of sales of $12.0 million and amortization of intangibles of $10.3 million. Source
  • Tax expense of $17.0 million: Tax expense was $17.0 million, compared with none in the first quarter of 2025, leaving net income at $38.6 million. Source
  • Other expense of $8.0 million: Total other expense was $8.0 million, including a $3.5 million unrealized loss on a marketable security and a $4.2 million change in contingent consideration. Source

Cash, balance sheet and buybacks

  • Operating cash flow was $42.4 million: Net cash provided by operating activities was $42.4 million, compared with $19.7 million in the first quarter of 2025. Source
  • Cash reached $178.1 million: Cash and cash equivalents were $178.1 million at March 31, 2026, excluding restricted cash, against $144.8 million at December 31, 2025. Source
  • Liquidity stated for twelve months: Management said current resources are sufficient to fund operations for at least twelve months from the issuance of the Form 10-Q. Source
  • Receivables down, inventory up: Trade receivables, net were $154.8 million at March 31, 2026, down from $171.2 million. Inventories were $30.7 million, up from $29.7 million. Source
  • Buyback program cited without new amount: The release cites stock repurchases but gives no amount for this quarter. The $75 million program approved in early February was reported in the prior release.
  • Diluted share count rose: Weighted average diluted shares were 93.0 million, against 69.0 million a year earlier. Basic weighted average shares were 79.5 million. Source

Pipeline and R&D

  • ReSPECT Phase III topline positive: The global ReSPECT Phase III trial of REZZAYO for prophylaxis in allogeneic stem cell transplant patients reported positive topline results on April 27, 2026. Source
  • R&D spend rose on pediatric and TPN work: R&D expense was $7.2 million, up from $3.2 million, for pediatric studies of several brands and continued DefenCath development for the TPN indication. Source
  • REZZAYO current approved uses: The prior release said REZZAYO is approved for candidemia and invasive candidiasis in adults, with the prophylaxis Phase III study ongoing at that time.

Coming up, as management said on 14 May 2026

  • REZZAYO sNDA submission planned: Management expects to prepare the FDA submission of the sNDA with its global partner in the second half of 2026. Source
  • Expanded REZZAYO launch targeted for 2027: The company is targeting a potential commercial launch of REZZAYO for the expanded indication in 2027. Source

Figures management reported

FigureReported
DefenCath net sales, Q1 2026 Source$97.5 million
Melinta portfolio revenue, Q1 2026 Source$29.9 million
R&D expense, Q1 2026 Source$7.2 million
ReSPECT Phase III topline, REZZAYO prophylaxis Sourcepositive, announced April 27, 2026
TPN Phase 3 study completion Sourcetrending to completion in 2028

Risks management discussed

  • Regulatory: Management referred to the pending expiration of TDAPA as a factor for DefenCath. The release gives no quantified effect of that expiration. Source
  • Operational: Management said enrollment in the TPN Phase 3 study is being accelerated, and the study is trending to completion in 2028. Source

Earlier plans management reported on

  • Not stated: The prior release expected ReSPECT data in Q2 2026. The current release reports the readout of that study.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.