CorMedix's Q3 2025: Key Contradictions Emerge on LDO Patient Rollout, Medicare Advantage Impact, and DefenCath Pricing Dynamics

Date of Call: November 12, 2025

Financials Results

• Revenue: $104.3M, up $77.5M YOY (DefenCath $88.8M; Melinta contribution ~$15.5M, incl. ~$12.8M portfolio sales)
• EPS: $1.26 per diluted share (net income $108.6M) vs. net loss of $2.8M and loss per diluted share $0.05 in Q3 2024

Guidance:

• Full-year pro forma combined revenue raised to $390–$410M (previously ≥ $375M).
• Pro forma fully synergized adjusted EBITDA for 2025 increased to $220–$240M (previously $165–$185M).
• Q4 net revenue guide $115–$135M; expect year-end cash ~ $100M.
• Expect to capture ~$30M run-rate synergies by end of 2025; recognize in P&L beginning Q4 2025.
• RESPECT (Rezeo) top-line expected Q2 2026; NutriGuard (TPN/CLABSI) completion targeted end 2026/early 2027.

Business Commentary:

• Transformative Acquisition and Financial Performance:
• CorMedix reported record revenue of $104.3 million, net income of $108.6 million, and adjusted EBITDA of $71.8 million for Q3 2025.

• The strong financial performance was driven by the successful acquisition and integration of Melinta Therapeutics, which contributed significantly to revenue growth.

• DefenCath Utilization and Market Expansion:

• 
• DefenCath showed faster-than-expected adoption by the LDO customer, with utilization growth from the existing customer base.

• The increase in utilization was attributed to rising demand from new cohorts and successful customer engagement strategies.

• Pipeline Development and Strategic Investments:

• CorMedix raised its pro forma combined full-year revenue guidance to $390-$410 million and increased adjusted EBITDA guidance to $220-$240 million for 2025.

• This was due to the successful strategic minority investment in Telfera, Inc., which provides access to a late-stage critical care product complementary to CorMedix's acute care portfolio.

• Integrated Operations and Synergies:

• The company expects to capture approximately $30 million of synergies on a run-rate basis by the end of 2025, ahead of initial estimates.
• These synergies were achieved through the integration of legacy CorMedix and Melinta operations, resulting in operational efficiencies and cost savings.

Sentiment Analysis:

Overall Tone: Positive

• Management highlighted "record levels for revenue of $104.3 million, net income of $108.6 million, and adjusted EBITDA of $71.8 million" and announced raising full-year revenue guidance to $390–$410M and adjusted EBITDA guidance to $220–$240M, citing faster-than-expected DefenCath adoption, Melinta contribution, and expected ~$30M run-rate synergies to be realized starting Q4 2025.

Q&A:

• Question from Les Suelski (Truist): Inventory stocking vs utilization in 3Q; seasonality and whether 4Q guidance represents normalized utilization; follow-up on whether RWE is tied to post-TDAPA pricing negotiations and pricing outlook heading into July.
  Response: Minimal abnormal Q3 stocking (customers holding ~2–4 weeks), utilization accelerating; no material seasonality expected; post-TDAPA pricing for fee-for-service depends on the ESRD final rule, while RWE will be used to negotiate separately with Medicare Advantage.

• Question from Jason Butler (Citizens): LDO ordering/use details (number and type of patients) and color on real-world data—patient counts, endpoints, and how to assess benefits vs. phase 3.
  Response: LDO utilization and ordering are faster than expected; patient count exceeds the prior 6,000 target but not disclosed; the RWE study includes ~2,000 patients (≈2x phase 3) measuring CRBSI reduction, CRBSI-related hospitalizations and secondary endpoints (mistreatment sessions, TPA and antibiotic use) with interim year-one results in ~6–7 weeks.

• Question from Rowena Ruiz (Lyrinc Partners): How to think about 2H 2026 revenues and pricing dynamics post-TDAPA and what data CorMedix is bringing to customer discussions for post-TDAPA negotiations.
  Response: Cannot provide definitive 2H 2026 revenue outlook yet; expect some price compression post-TDAPA driven by CMS methodology in the ESRD rule; the company will use interim RWE and observed infection reductions to negotiate with customers and Medicare Advantage plans.

• Question from Brandon Foakes (HC Wainwright): Progress/opportunity for DefenCath inpatient adoption leveraging Melinta relationships and outlook on the NIAID/Telfera investment and required commercial investment if exercised.
  Response: Inpatient uptake is smaller than outpatient but steadily growing and higher revenue-per-patient; integrated salesforce will promote inpatient starting Jan 2026; Telfera aligns well with existing commercial call points and could be EBITDA-accretive, though some marketing/commercial investment may be required pending clinical results.

• Question from Sergey Belenzey (Needham & Company): Update on DefenCath pricing in 3Q, ability to provide guidance after ESRD final rule, and awareness of legislation that could change TDAPA reimbursement.
  Response: Not disclosing specific pricing; modest quarter-to-quarter ASP erosion is being offset by volume; the ESRD final rule will determine post-TDAPA fee-for-service pricing and guide contractual discussions; bipartisan legislation has been proposed to extend ASP period and change post-TDAPA add-on methodology toward drug-claim–based allocation.

• Question from Dan Fairey (written): What is misunderstood about the Melinta transaction and why investors may not be crediting its value?
  Response: Melinta provides a stabilizing base of revenue and risk mitigation while adding a commercial portfolio; management believes investors underappreciate pipeline upside (notably Rezeo prophylaxis and the TPN CLABSI opportunity) which may exceed DefenCath peak sales potential.

Contradiction Point 1

LDO Patient Rollout and Expectations

It involves differing expectations and timelines regarding the patient rollout and implementation of DefenCath with the LDO, which could impact sales forecasts and investor expectations.

Can you share information about the number and types of patients the LDO has used the product with? - Jason Butler (Citizens)

2025Q3: The LDO's patient rollout is higher than initially targeted, but exact numbers aren't provided. - Joe Todisco(CEO)

Any updates on the LDO's expected timeline and implementation status? - Roana Ruiz (Leerink Partners)

2025Q1: We are still working off prior feedback on patient numbers but are prepared for scalability. - Joe Todisco(CEO)

Contradiction Point 2

Real-World Evidence and Medicare Advantage Impact

It highlights the evolving expectations and timelines related to real-world evidence generation and the impact of Medicare Advantage, which are crucial for understanding market dynamics and reimbursement strategies.

Does real-world evidence align with final pricing agreements in the post-TDAPA period? - Les Suelski (Truist)

2025Q3: Real-world evidence is most applicable to Medicare Advantage, which isn't bound by post-TDAPA add-on. The TDAPA add-on is based on the ESRD final rule, which will determine the price. - Joe Todisco(CEO)

What is the outlook for patient applicability under TDAPA and what trends are expected in Medicare Advantage over the next two to three years? - Anish Nikhanj (RBC Capital Markets)

2024Q4: Initially, 100% of claims were fee-for-service, but now 40% are Medicare Advantage. We see Medicare Advantage growing to 70% of ESRD patients. The real-world evidence study will help in direct contract negotiations with EMA plans. - Joseph Todisco(CEO)

Contradiction Point 3

Melinta's Integration and Product Focus

It highlights differing perspectives on the focus and integration strategy for Melinta's products, which impact the company's growth trajectory.

How do you assess the DefenCath inpatient opportunity? How do you expect it to develop in 2026? - Brandon Foakes (HC Wainwright)

2025Q3: We've seen good progress in the inpatient segment, but it's not as significant as the outpatient increase. We're integrating our field teams to promote DefenCath in the inpatient setting in January 2026, which we expect to drive growth. - Joe Todisco(CEO)

What is the growth potential of Melinta's approved portfolio and hospital commercial infrastructure? - Jason Nicholas Butler (Citizens JMP Securities, LLC)

2025Q2: Melinta's portfolio has growth potential, with REZZAYO's expanded indication as the main driver. Existing products like MINOCIN, VABOMERE, and others have some upside. The combination of our strong team and Melinta's strong team will form a robust commercial infrastructure. - Joseph Todisco(CEO & Director)

Contradiction Point 4

Inpatient Sales Team Ramp and Market Share Target

It reveals differing expectations regarding the ramp-up of the inpatient sales team and the targeted market share for DefenCath in the inpatient setting, which impacts growth strategies and investor expectations.

What's your outlook for the DefenCath inpatient opportunity and expectations for its 2026 progress? - Brandon Foakes (HC Wainwright)

2025Q3: We've seen good progress in the inpatient segment, but it's not as significant as the outpatient increase. We're integrating our field teams to promote DefenCath in the inpatient setting in January 2026, which we expect to drive growth. - Joe Todisco(CEO)

What are the initial steps for the Syneos Health partnership and inpatient sales team building? What is the growth plan for DefenCath in the inpatient setting? - Roanna Clarissa Ruiz (Leerink Partners)

2024Q4: Inpatient is about 3% of unit volume and 4% to 5% of dollars. Our target is to achieve 10% of the overall market opportunity. - Joseph Todisco(CEO)

Contradiction Point 5

DefenCath Pricing and Market Dynamics

It involves changes in pricing dynamics and market conditions for DefenCath, which directly impacts revenue forecasts and strategic planning.

Can you provide an update on DefenCath pricing for Q3? - Sergey Belenzey (Needham & Company)

2025Q3: Pricing erosion is tracked quarterly, but volume growth offsets it. We'll adjust based on the TDAPA rule. - Joe Todisco(CEO)

What are the guidance dynamics for DefenCath's revenue and the sensitivity of the ramp? - Anish Nikhanj (RBC Capital Markets)

2025Q2: DefenCath's guidance is based on customer orders and a conservative ramp. There's potential upside, but we've set the range to account for that. - Joseph Todisco(CEO & Director)