CorMedix Inc. (CRMD)·Q3 2025 Earnings Summary

Executive Summary

• Q3 delivered record net revenue of $104.3M and diluted EPS of $1.26, materially above S&P Global consensus ($86.0M revenue, $0.63 EPS); management raised FY25 pro forma revenue guidance to $390–$410M and guided Q4 revenue to $115–$135M, with pro forma fully-synergized adjusted EBITDA raised to $220–$240M . S&P Global estimates used for consensus comparison.*
• Outperformance was driven by faster-than-expected DefenCath adoption at the large dialysis organization (LDO) and continued utilization growth; DefenCath contributed $88.8M of net revenue in Q3, with ~2–4 weeks on-hand inventory at customers and minimal Q3 stocking impact .
• The Melinta acquisition (closed Aug 29) contributed ~$12.8M of September portfolio sales in Q3; integration is ahead of plan with ~$30M run-rate synergies expected by year-end 2025, supporting the guidance raise .
• Key 2026 catalysts beyond hemodialysis include ReSPECT Phase 3 prophylaxis data for REZZAYO in 2Q26 and DefenCath TPN Phase 3 progress; management emphasized post-TDAPA strategy (Medicare Advantage contracting) and pending ESRD final rule for 2H26 pricing .

What Went Well and What Went Wrong

• What Went Well

  • “Most successful quarter…record levels for revenue of $104.3 million, net income of $108.6 million, and adjusted EBITDA of $71.8 million,” driven by accelerated DefenCath LDO adoption and contribution from Melinta .
  • Guidance raised: FY25 pro forma revenue to $390–$410M; Q4 revenue to $115–$135M; FY25 fully-synergized pro forma adjusted EBITDA to $220–$240M .
  • Integration ahead of plan with ~$30M run-rate synergies by year-end; rebranding to CorMedix Therapeutics aligns the combined portfolio and culture for execution .

• What Went Wrong

  • Gross margin compressed to ~89% in Q3 (vs ~95% in 1H25), reflecting amortization of intangibles and mix post-Melinta; operating expenses rose to $41.7M (+197% y/y) on transaction/integration/severance and added OpEx from Melinta .
  • EPS benefited from a one-time $59.7M tax benefit from recognizing deferred tax assets; while supportive of cash taxes, this non-operating item drove a large portion of GAAP EPS upside .
  • Visibility on 2H26 post-TDAPA pricing remains uncertain pending the ESRD final rule and potential legislation; management flagged likely price compression in H2’26 absent legislative change .

Financial Results

Core P&L vs Prior Quarters and Consensus

Notes: Consensus from S&P Global; surprises calculated vs S&P Global consensus. Q3 EPS benefited from a one-time ~$59.7M tax benefit .
Asterisk indicates S&P Global data.*

Revenue Composition (Q3 2025)

Balance Sheet/Cash

• Cash and short-term investments (ex. restricted) at 9/30/25: $55.7M; guided to year-end cash of ~ $100M, driven by Q4 operations and working capital optimization .
• Convertible notes: $150M gross proceeds used to fund Melinta acquisition alongside stock consideration .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “This past quarter marks the most successful quarter…record levels for revenue of $104.3 million, net income of $108.6 million, and adjusted EBITDA of $71.8 million,” driven by LDO adoption and Melinta assets .
• “We are raising our pro forma combined full-year revenue guidance…to $390–$410 million” and fully-synergized adjusted EBITDA to $220–$240 million .
• On post-TDAPA: “There should be a little bit of front-endedness to overall revenue…A big part of our post-TDAPA strategy is the engagement with Medicare Advantage” .
• On 2H26 pricing: “We do know there’s going to be price compression…awaiting a final determination in the ESRD final rule” .
• On synergies: “Capture approximately $30 million…on a run-rate basis before the end of 2025” .

Q&A Highlights

• Inventory/Utilization: Typical weeks on hand ~2–3 (smaller customers) and 3–4 (LDO); “couple million dollars” at quarter cutover pulled into Q3—limited stocking effect overall .
• TDAPA/ESRD rule: Expect H2’26 price compression absent legislation; considering blended pricing based on final methodology .
• Medicare Advantage: RWE aimed at MA contracting (not bound by post-TDAPA add-on) to offset fee-for-service constraints .
• LDO rollout: “Significantly higher than 6,000 patients” initial target; exact number not disclosed .
• RWE readout: ~2,000 patients; endpoints include CRBSI and hospitalization reduction plus secondary antibiotic/TPA use; results in 6–7 weeks from call .
• Inpatient: Steady growth; unified field team to promote in hospitals starting Jan 2026 .
• Policy: Bipartisan bill would extend ASP period (2→3 years) and make a utilization-based permanent add-on; could improve post-TDAPA economics if enacted .

Estimates Context

• Q3 results beat consensus: revenue $104.3M vs $86.0M estimate (+21%); GAAP diluted EPS $1.26 vs $0.63 estimate (+$0.63). EPS included a one-time ~$59.7M tax benefit; adjusted EBITDA was $71.9M . Consensus from S&P Global.*
• Prior quarters also exceeded: Q1 revenue $39.1M vs $36.0M est; EPS $0.30 vs $0.25; Q2 revenue $39.7M vs $35.9M; EPS $0.28 vs $0.19.*

Note: S&P Global consensus used for estimates; values marked with an asterisk are from S&P Global.*

Key Takeaways for Investors

• Broad-based beat plus higher FY guidance underscores durability of DefenCath adoption and early portfolio contribution from Melinta; watch for sustained utilization vs limited inventory effects into Q4 .
• GAAP EPS was flattered by a large non-recurring tax benefit; adjust your framework to operating metrics (adjusted EBITDA, cash generation) for run-rate profitability .
• Post-TDAPA is the key 2026 debate: expect pricing pressure in 2H26 absent policy change; management’s MA strategy and RWE readout are critical mitigants .
• Integration momentum is real: ~$30M run-rate synergies by YE25 and a unified field force in early 2026 should support margin resilience post-TDAPA .
• 2026 pipeline catalysts (REZZAYO prophylaxis data in 2Q26 and DefenCath TPN expansion) can diversify growth beyond hemodialysis and offset reimbursement risk .
• Liquidity set to improve by YE25 (~$100M cash target) as working capital normalizes and Q4 revenue ramps (full-quarter Melinta) .
• Near-term focus: Q4 delivery vs $115–$135M guide, RWE readout by year-end, ESRD final rule timing/methodology, and early 2026 commentary on post-TDAPA pricing .

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Footnote: S&P Global consensus estimates used for revenue and EPS comparisons and shown with an asterisk. Values retrieved from S&P Global.*