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CI

Ceribell, Inc. (CBLL)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $20.49M, up 42% year over year and 11% sequentially; gross margin was 88%. Management raised FY2025 revenue guidance to $83–$87M from $81–$85M, citing broad-based adoption and stronger visibility .
  • Results beat Wall Street consensus: revenue by ~$1.19M and EPS by ~$0.10; management acknowledged an approximate $1M beat and raised FY guide more than the beat due to improved execution confidence .
  • Strategic advances: FDA 510(k) clearance for pediatric Clarity (ages ≥1) and FedRAMP High authorization, expanding addressable market and enabling broader government deployments; active accounts rose to 558 (+29 q/q) .
  • Tariffs risk timing: no material gross margin impact until at least Q4 2025 given FIFO inventory; full tariff impact estimated at <10 margin points post-inventory, with mitigation plans (automation, vendor negotiations, potential reshoring) .
  • Near-term cadence: management noted winter seasonality boosted Q1 utilization; expects potential utilization moderation in Q2 before re-acceleration later in the year .

What Went Well and What Went Wrong

What Went Well

  • Strong growth and beat: revenue $20.49M (+42% y/y; +11% q/q) and gross margin 88%; CFO: “we now expect full year 2025 total revenue to range from $83M to $87M” .
  • Strategic milestones: FDA clearance for pediatric Clarity and FedRAMP High authorization; CEO: “Clarity is now the first and only FDA‑cleared seizure detection algorithm indicated for patients aged 1 year and above… FedRAMP High… only medical device manufacturer to have received this authorization” .
  • Account expansion: active accounts reached 558 (+29 in Q1) with strong utilization; CEO: “continued success in acquiring and launching new accounts while also driving utilization” .

What Went Wrong

  • Operating expense ramp: OpEx rose to $32.21M (+55% y/y) as the company invests in commercial/R&D and public-company costs; noncash stock-based comp was $2.3M in Q1 and guided to ~$50M for FY2025 .
  • Continued net losses: Q1 net loss was $(12.78)M; EPS $(0.36), reflecting growth investments despite strong margin profile .
  • Tariff overhang: management outlined potential gross margin headwinds starting Q4 2025 under proposed 145% tariffs on imports from China, albeit mitigated by inventory timing and action plans .

Financial Results

Headline P&L and Operating Metrics

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$17.20 $18.53 $20.49
Gross Profit ($USD Millions)$15.01 $16.24 $18.01
Gross Margin %87% 88% 88%
Operating Expenses ($USD Millions)$24.95 $29.12 $32.21
Net Loss ($USD Millions)$(10.42) $(12.58) $(12.78)
Diluted EPS ($USD)$(1.85) $(0.40) $(0.36)
Active Accounts (#)504 529 558
Cash & Equivalents ($USD Millions)$14.11 $194.37 $153.36
Sequential Revenue Growth %—Implied growth vs Q3 11% vs Q4
YoY Revenue Growth %48% 41% 42%

Segment Breakdown

MetricQ3 2024Q4 2024Q1 2025
Product Revenue ($USD Millions)$13.32 $14.15 $15.61
Subscription Revenue ($USD Millions)$3.87 $4.39 $4.88
Subscription Gross Margin %——97% (subscription products, stated)

KPIs

KPIQ3 2024Q4 2024Q1 2025
Active Accounts (#)504 529 558
Gross Margin %87% 88% 88%
Noncash Stock-Based Comp ($USD Millions)—$2.2 (Q4) $2.3 (Q1)

Actual vs S&P Global Consensus (Q1 2025)

MetricConsensusActual# of Estimates
Revenue ($USD Millions)$19.30M*$20.49M 5*
EPS ($USD)$(0.4567)*$(0.36) 3*

Estimates marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenue ($USD Millions)FY 2025$81–$85M $83–$87M Raised (midpoint +$2M)
Gross Margin %FY 2025Mid-to-high 80% range Mid-80% range; <10pp potential impact post-inventory under proposed tariffs Maintained range; added tariff sensitivity
Stock-Based Compensation ($USD Millions)FY 2025~ $15M ~ $50M Raised materially
Cash Flow BreakevenMulti-year“Achieve breakeven with cash on hand” “Reach cash flow breakeven with current cash on hand” Maintained confidence

Earnings Call Themes & Trends

TopicQ3 2024Q4 2024Q1 2025Trend
AI/Tech & PipelineEmphasis on Clarity/ClarityPro; NTAP reimbursement; pipeline in delirium/stroke Delirium breakthrough designation; stroke dataset >200 patients; neonate Clarity timing Pediatric Clarity FDA clearance; neonate/delirium timelines reiterated Advancing indications
Supply Chain/Tariffs—Tariffs increased to 35%; margin guidance mid-to-high 80% Proposed 145% tariffs; no impact until ≥Q4 2025; <10pp margin effect post-inventory; mitigation plans Heightened risk, mitigations ready
Commercial ExecutionActive accounts 504; strong utilization 529 accounts; cadence planning (no mid-Dec launches) 558 accounts; continued CAM-driven usage growth Expanding footprint
Government AccessVA ATO enabling ~200 VA hospitals —FedRAMP High authorization; validation of cybersecurity Broadening access
SeasonalityUsage higher in Q3/Q4 vs Q2 Winter seasonality commentary Expect Q2 moderation; longer-term utilization growth intact Seasonal ebb/flow
Pricing—“Pricing discipline” supports margins No tariff-based price changes assumed; modest increases; rolling contract cycle Stable pricing posture
R&D ExecutionPlan to expand indications (delirium, stroke) Filing for pediatric; delirium submission prep Pediatric cleared; neonate/delirium on track Progressing per plan
NTAP/ReimbursementNTAP up to $913.90 per eligible patient —NTAP referenced indirectly via subscription value Sustained support

Management Commentary

  • CEO: “We are pleased with our strong start to the year… We see 2025 as another momentous year of growth… goal of ultimately making EEG a new vital sign” .
  • CEO: “Clarity is now the first and only FDA‑cleared seizure detection algorithm indicated for patients aged 1 year and above” .
  • CFO: “We now expect full year 2025 total revenue to range from $83 million to $87 million… representing annual growth of 27% to 33% over 2024” .
  • CFO (tariffs): “We do not expect to see any material impact… until at least the fourth quarter of 2025… impact… less than 10 percentage points… we are actively considering reshoring” .
  • CEO: “As of March 31, 2025, we had 558 active accounts… we are still in the early stage of the adoption curve” .

Q&A Highlights

  • Beat/raise dynamics: Management confirmed ~$1M revenue beat vs consensus and raised FY guide more than the beat due to stronger visibility and execution across acquisition and CAM strategies .
  • Tariff mitigation: Detailed actions include automation, vendor cost negotiation, shipping efficiencies, and potential reshoring; impact expected to be transient with medium-term gross margin around ~80% and path back to mid-80% longer term .
  • Seasonality/utilization: Winter ICU census boosted Q1; expects potential utilization dip in Q2 before seasonal recovery; long-term penetration remains only ~20–30% of patient populations in existing accounts .
  • Pediatric Clarity: No contribution assumed in FY2025; limited commercial release and pilot in 2025, broader launch thereafter .
  • Pricing/contracts: No tariff-driven price increases in guidance; contracts typically 1–2 years with rolling expirations .
  • VA/government: FedRAMP High and prior VA ATO open doors; expect typical hub-and-spoke expansion in networks over time .

Estimates Context

  • Q1 2025 results beat S&P Global consensus: revenue $20.49M vs $19.30M* and EPS $(0.36) vs $(0.4567)*; management cited ~$1M beat and raised FY guide on execution confidence .
  • FY2025 consensus revenue was ~$88.19M*, above the raised company range; Sell-side may recalibrate quarterly cadence given seasonality commentary and tariff timing .

Estimates marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Strong Q1 execution with broad-based growth, high gross margin, and beat vs consensus underpinning a guidance raise; adoption and utilization remain the primary growth levers .
  • Near-term caution: Q2 could show utilization moderation on normal seasonality; watch for a reacceleration into Q4 as winter ICU census improves .
  • Tariff overhang likely delayed until Q4 2025 due to FIFO inventory; monitor policy clarity and the timing/extent of mitigation (automation, cost-downs, reshoring) .
  • Opex intensity continues as the company accelerates commercial and R&D investments; FY2025 stock-based comp guide raised to ~$50M—watch operating leverage trajectory and cash burn vs “breakeven with cash on hand” commitment .
  • Strategic catalysts: Pediatric Clarity clearance expands TAM; neonate and delirium programs are on track; FedRAMP High plus VA ATO broaden government channel opportunities .
  • Reimbursement tailwinds (NTAP) and subscription margins (97%) support durable margin profile and recurring revenue mix, partially shielding tariffs .
  • Actionable: Expect sell-side to fine-tune quarterly paths but maintain constructive full-year stance; focus on execution in account adds, CAM-driven utilization, and tariff mitigation updates as stock catalysts .
Notes:
- All financial and strategic statements are sourced from company documents and earnings calls as cited above.
- Estimates marked with * retrieved from S&P Global.