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CI

CorMedix Inc. (CRMD)·Q4 2024 Earnings Summary

Executive Summary

  • Beat across the board with first profitable quarter: Q4 revenue $31.21m and GAAP EPS $0.22, both ahead of consensus ($28.35m revenue, $0.14 EPS); adjusted EBITDA was $15.3m, driven by outpatient DefenCath uptake. *
  • Management set preliminary H1 2025 net revenue guidance at $50–$60m (Q1 >$33m), reiterated FY25 cash OpEx guidance of $72–$78m, and expects >$75m cash and ST investments at Q1-end, supporting continued commercialization and clinical investment.
  • Commercial execution positive in outpatient; inpatient traction building with a dedicated Syneos Health team launching early Q2 and VA promotional support underway. Large dialysis organization (LDO) rollout was pushed into 2025 but could start by midyear.
  • Watch items for stock narrative: net price erosion expected starting Q2 2025 and a potential Q2 shelf stock adjustment; magnitude depends on channel inventory. A midyear LDO implementation and policy tailwinds (CMMI TDAPA carve-out) are key catalysts.

What Went Well and What Went Wrong

What Went Well

  • First profitable commercial quarter in company history: Q4 net income $13.5m; adjusted EBITDA $15.3m, as outpatient DefenCath adoption scaled across anchor and midsize dialysis operators. “The fourth quarter was also the first profitable commercial quarter in the company's history.”
  • Guidance and liquidity supportive: H1’25 net revenue guided to $50–$60m (Q1 >$33m) and cash/short-term investments expected >$75m at Q1-end, backing operating and clinical plans.
  • Reimbursement/policy tailwinds: CMMI’s KCC model now carves out TDAPA starting Jan 2025, removing a headwind to adoption across value-based entities; management saw a patient lift at U.S. Renal Care following the change.

What Went Wrong

  • LDO rollout delay: Contracted LDO implementation slipped into 2025 due to resource constraints; management is “hopeful” for orders before midyear, but timing and scale remain uncertain.
  • Price pressure ahead: Management expects net price erosion to begin in Q2 2025 and is planning a shelf stock adjustment entering Q3; impact depends on Q2 channel inventory.
  • Inpatient start slower than hoped: “A little bit slow out the gate” due to P&T timelines; inpatient is ~10% of market units, and management is targeting a more meaningful contribution by 2026 after deploying a dedicated Syneos hospital team.

Financial Results

P&L summary (oldest → newest)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($)$0.81m $11.46m $31.21m
Net Income ($)$(14.15)m $(2.78)m $13.46m
EPS (GAAP, basic)$(0.25) $(0.05) $0.22
Total Operating Expenses ($)$15.60m $14.06m $17.10m

Margins and profitability (oldest → newest)

MetricQ2 2024Q3 2024Q4 2024
Gross Profit Margin %36.75%*94.46%*96.23%*
EBITDA ($)$(15.22)m*$(3.21)m*$13.10m*
EBITDA Margin %N/M*(28.02%)*41.88%*
Adjusted EBITDA ($, Company)N/AN/A$15.33m

Asterisk indicates values retrieved from S&P Global.

Q4 vs Estimates

MetricActual (Q4 2024)Consensus (Q4 2024)Surprise
Revenue ($)$31.21m $28.35m*+$2.86m / +10.1%*
EPS (GAAP)$0.22 $0.14*+$0.08*

Asterisk indicates values retrieved from S&P Global.

KPIs and other items

KPIQ4 2024
Cash & Short-term Investments (12/31/24)$51.7m
Operating Expenses (Q4)$17.1m (+9% YoY)
Open POs for Q1 2025>$25m (as of Jan 7, 2025)
Outpatient coverage (as of Q3)Access to ~60% of US outpatient dialysis centers

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net RevenueH1 2025N/A$50–$60m; Q1 >$33m New
Cash Operating ExpensesFY 2025$72–$78m (prelim., Jan 7, 2025) Reiterated $72–$78m Maintained
Cash & ST InvestmentsQ1 2025 (end)N/A>$75m expected New outlook

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024 call)Trend
Outpatient adoptionQ2: initial inpatient launch; early outpatient sales in July with $5.2m QTD as of Aug 13 . Q3: first full outpatient quarter, $11.5m; access to ~60% of outpatient centers .Outpatient drove strong Q4; U.S. Renal Care anchor plus midsize customers; H1’25 guide $50–$60m from existing base .Accelerating base; scale-up continues into 1H25.
LDO implementationQ3: commercial agreement with an LDO; working to initiate utilization in Q4 .Implementation pushed into 2025; CorMedix providing training/reimbursement support; hopeful for ordering by midyear .Delay; midyear 2025 is key swing factor.
Inpatient strategyQ2/Q3: early pull-through; P&T processes underway .Dedicated Syneos inpatient team nearly staffed; expected to be active within 4–5 weeks; inpatient ~3% of units and 4–5% of dollars YTD Q1; target meaningful growth by 2026 .Building infrastructure; inflect gradual.
Pricing/ASP dynamicsNot previously quantified.Expect net price erosion starting Q2 2025; potential Q2 shelf stock adjustment ahead of Q3 ASP reset; impact depends on channel inventory .New headwind emerging in 2025.
Reimbursement/Policy—CMMI KCC change carves out TDAPA from benchmarks as of Jan 2025; management saw 15–20% patient lift at U.S. Renal Care; Medicare Advantage claims mix trending toward ~40% in Q1 .Policy tailwinds; payer mix shifting MA.
Clinical expansionQ2/Q3: TPN protocol moving to FDA; RWE and pediatric studies planned .TPN Phase 3 site selection begun; enrollment expected Q2 2025; orphan drug application submitted; RWE study underway; pediatric HD study to start Q3 2025 .Advancing pipeline enablers.
Supply/manufacturing—>1 year of finished dosage on hand at current run-rate; multiple CMOs, raw materials sufficient; ramp time “handful of months” if needed .Adequate capacity with flexibility.

Management Commentary

  • “Net revenue for the fourth quarter and full year were $31.2 million and $43.5 million, respectively, both of which exceeded Wall Street consensus prior to our preannouncement on January 7.”
  • “The fourth quarter was also the first profitable commercial quarter in the company's history with net income of $13.5 million and adjusted EBITDA of $15.3 million.”
  • On inpatient rollout: “We were a little bit slow out the gate... It takes quite a while to work through P&T processes... the new inpatient team is nearly fully staffed and is expected to be active in the field in the next 4 to 5 weeks.”
  • On pricing: “We do expect to begin to see some net price erosion beginning in the second quarter of 2025... expecting to take a shelf stock adjustment at the end of the second quarter.”
  • On policy: “We did see [a] patient lift of somewhere around 15% to 20%... with U.S. Renal Care... [from the CMMI benchmark change].”

Q&A Highlights

  • LDO timing and scale: CorMedix is providing training and reimbursement support; still targeting midyear 2025 for initial orders, but magnitude remains uncertain.
  • Inpatient contribution/run-rate: Early Q1 view had ~3% of units and 4–5% of dollars from inpatient; targeting movement toward ~10% of total unit volume (market mix) over time.
  • Pricing mechanics: Net price erosion tied to ASP and contractual rebates; a Q2 shelf stock adjustment is likely, with impact dependent on channel inventory by quarter-end.
  • Payer mix: Medicare Advantage claims increased from ~25–30% exiting 2024 to ~40% in early Q1 2025; management views MA growth as an opportunity with future direct contracting informed by RWE.
  • Capacity: >1 year finished dosage on hand at current run-rate; CMOs underutilized; raw materials secured; can ramp within a “handful of months” if LDO scaling exceeds plan.

Estimates Context

  • Q4 2024 results exceeded S&P Global consensus: revenue $31.21m vs $28.35m*, and EPS $0.22 vs $0.14*. *
  • Prior quarters showed positive estimate momentum: Q3 revenue $11.46m vs $10.84m* and EPS $(0.05) vs $(0.105); Q2 under-revenue but in line EPS.
  • Consensus for FY 2024 EPS was $(0.373)* vs actual $(0.30), reflecting a better-than-expected profitability ramp into year-end. *

Asterisk indicates values retrieved from S&P Global.

Key Takeaways for Investors

  • CorMedix delivered a clean beat/raise quarter with the first profitable quarter driven by outpatient execution; the H1’25 revenue guide anchors near-term visibility while preserving upside from LDO timing.
  • The LDO rollout is the principal swing factor for 2H’25 trajectory; a midyear start could unlock substantial volume and accelerate revenue beyond the base-business guide.
  • Expect some gross-to-net pressure starting Q2 2025 and a Q2 shelf stock adjustment; monitor channel inventories and ASP resets as potential sources of near-term volatility.
  • Policy momentum (TDAPA carve-out in KCC) and a rising Medicare Advantage mix are tailwinds for broader adoption and could support more durable reimbursement via direct MA contracting informed by RWE.
  • Inpatient is building from a low base; the dedicated Syneos team and VA focus should support contribution growth into 2026, diversifying settings of care.
  • Liquidity is solid (> $75m expected at Q1-end), funding commercialization and key clinical catalysts (TPN Phase 3 start, pediatric HD study, RWE output) that can expand addressable markets.
  • Setup: Beat quarter, visibility on H1, identifiable catalysts (LDO, policy, clinical starts) vs. manageable headwinds (price erosion, channel adjustment) — constructive risk/reward into mid-2025 if execution on LDO and inpatient scaling materializes.

Notes:

  • Company financials and guidance sourced from the 8-K/press release and Q4’24 call.
  • Estimates marked with an asterisk (*) are values retrieved from S&P Global.