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GRAIL, Inc. (GRAL)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 revenue grew 26% year over year to $36.2M, with screening revenue up 29% to $32.8M and U.S. Galleri revenue up 28% to $32.6M; adjusted EBITDA improved to $(71.7)M and adjusted gross profit rose to $20.0M .
  • The company delivered a modest revenue beat versus consensus and a significant EPS beat: revenue $36.19M vs $35.40M consensus (+$0.79M, +2.2%), and EPS $(2.46) vs $(3.48) consensus (+$1.02); consensus coverage remains thin (3 estimates)*.
  • Guidance tightened and de-risked: FY25 U.S. Galleri revenue growth refined to the midpoint of the prior 20–30% range, and cash burn guidance lowered to ≤$290M; PMA submission timeline accelerated to Q1 2026 .
  • Strategic and financing updates extend runway: $325M private placement in October and planned $110M Samsung investment support cash runway “into 2030” and international expansion in Asia; Canada commercial intro with Medcan/Manulife .
  • Fundamental narrative strengthened by positive clinical evidence: PATHFINDER 2 showed 61.6% PPV, 99.6% specificity, and seven-fold higher cancer detection when added to recommended screenings; SYMPLIFY follow-up PPV increased to 84.2% .

What Went Well and What Went Wrong

What Went Well

  • Volume and revenue growth: Galleri tests sold grew 39% YoY to “more than 45,000,” with total revenue +26% and screening revenue +29% YoY; CEO: “We remain very pleased by Galleri’s commercial uptake” .
  • Margins and efficiency: Non-GAAP adjusted gross margin improved to 55% (from 41% in Q3’24) driven by variable cost reductions and lab efficiency at higher volumes; CFO highlighted platform throughput and fixed-cost leverage .
  • Clinical validation and regulatory progress: PATHFINDER 2 and SYMPLIFY updated results bolster evidence; PMA timeline clarified to Q1 2026; CEO: “We anticipate completing our PMA submission… in the first quarter of 2026” .

What Went Wrong

  • ASP pressure and reprocessing: CFO noted decreased ASP and higher sample reprocessing costs partially offset margin improvements, a watchpoint for sustainability as promotional pricing ($150 off) was used to drive prescribing depth .
  • Development services softness: Development services revenue was $3.4M, up slightly YoY but down from prior levels versus last year’s nine-month period decline; the mix remains heavily dependent on screening revenue .
  • Continued GAAP losses: Net loss remained large at $(89.0)M, albeit improved YoY; GAAP gross loss of $(13.7)M underscores reliance on non-GAAP improvements and scale to reach breakeven .

Financial Results

Revenue and EPS vs Prior Quarters and Estimates

MetricQ1 2025Q2 2025Q3 2025
Total Revenue ($USD Millions)$31.84 $35.54 $36.19
Net Loss per Share (EPS) ($USD)$(3.10) $(3.18) $(2.46)
Revenue YoY Growth (%)19% 11% 26%
Revenue Consensus Mean ($USD Millions)*$35.20$36.90$35.40
EPS Consensus Mean ($USD)*$(3.99)$(3.64)$(3.48)
Revenue Beat/(Miss) ($USD Millions)*$(3.36)$(1.36)+$0.79
EPS Beat/(Miss) ($USD)*+$0.89+$0.46+$1.02

Values retrieved from S&P Global.*

Margins and Profitability (Non-GAAP where noted)

MetricQ1 2025Q2 2025Q3 2025
Adjusted Gross Profit ($USD Millions)$14.31 $16.11 $20.01
Adjusted EBITDA ($USD Millions)$(98.74) $(78.32) $(71.70)
Adjusted Gross Margin (%)——55%

Segment Breakdown

MetricQ1 2025Q2 2025Q3 2025
Screening Revenue ($USD Millions)$29.13 $34.38 $32.81
Development Services Revenue ($USD Millions)$2.70 $1.17 $3.39
Total Revenue ($USD Millions)$31.84 $35.54 $36.19

Key Performance Indicators (KPIs)

KPIQ1 2025Q2 2025Q3 2025
Galleri Tests Sold (units)>37,000 >45,000 >45,000
U.S. Galleri Revenue ($USD Millions)$28.7 $34.2 $32.6
Cash, Equivalents, Restricted, ST Investments ($USD Millions)$677.9 $606.1 $547.1
Liquidity Runway (post-Oct financing)——“into 2030”

Note: CFO transcript mislabels “Q4” when discussing Q3 figures; confirm with 8-K and press release values -.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
U.S. Galleri Revenue Growth (YoY)FY 202520%–30% Refined to midpoint of range Maintained/Refined
Cash BurnFY 2025≤$310M (Aug) ≤$290M (net of $13M fees) Lowered
PMA Submission (Galleri)Regulatory TimelineH1 2026 (prior) Q1 2026 Accelerated
Liquidity RunwayMulti-yearInto 2028 (Q1) Into 2030 (post financing) Extended

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3)Trend
Regulatory (PMA timeline)Planned PMA completion in H1’26 PMA submission now anticipated Q1’26 Accelerating
Clinical Evidence (PATHFINDER 2, NHS)NHS prevalent round PPV substantially higher than PATHFINDER; consistent specificity/CSO PATHFINDER 2: PPV 61.6%, specificity 99.6%, seven-fold detection gain Strengthening
International ExpansionPartnerships (athenahealth, Everlywell) and health system adoption Samsung LOI for Asia; Canada launch with Medcan/Manulife Expanding
Pricing/ASP and PromotionsStreamline ordering/integration; focus on access Website discount ($150 off); elasticity leveraged; ASP decrease noted Mixed (growth aided, ASP pressure)
Cost Structure & MarginsVariable cost improvements and platform scaling discussed Adj. gross margin 55%; fixed-cost leverage at higher volumes Improving
SeasonalityHigh in Q2/Q4, lower in Q1/Q3 Q3 growth outpaced expected seasonal softness Positive vs seasonality
Liquidity/Capital$677.9M cash/investments; runway into 2028 $325M private placement; Samsung $110M planned; runway into 2030 De-risked

Management Commentary

  • CEO on commercial momentum: “We remain very pleased by Galleri’s commercial uptake with 39% growth in Galleri test volume in the third quarter… Looking ahead, we anticipate completing our PMA submission… in the first quarter of 2026” .
  • CFO on margins and efficiency: “In Q3, we achieved a non-GAAP adjusted gross margin of 55%… driven by improvements in variable costs… and higher lab efficiency at higher volumes” .
  • President on clinical results: “Adding Galleri… yielded a more than seven-fold increase in the overall cancer detection rate… PPV was 61.6%… Specificity was 99.6%” .
  • CSO on SYMPLIFY follow-up: “Approximately one-third… initially believed to be false positives were diagnosed with cancer… updated PPV… increased to 84.2%” .
  • CEO on timeline clarity: “We’ve been saying first half for a fair amount of time… more confident to put it… for the first quarter [2026]” .

Q&A Highlights

  • PMA timing tightened: Management now expects PMA submission in Q1 2026, citing greater internal confidence in deliverables and timeline .
  • Pricing elasticity and ASP: Website promotion ($150 off) aimed at deepening provider prescribing and repeat testing; management acknowledged price elasticity and ASP decline impacts on margins .
  • Capital deployment and competition: Additional capital provides flexibility to “flex” commercial investments amid emerging competition; momentum cited post-PATHFINDER 2 .
  • NHS-Galleri data context: NHS sought “exceptional” early data to accelerate; broader data will be in PMA but not public until final trial readout (mid-2026) .
  • Cost per-test improvements: Significant year-over-year declines in per-test costs driven by platform throughput and variable cost efficiencies, enhancing fixed-cost leverage .

Estimates Context

  • Q3 delivered a modest revenue beat and a significant EPS beat versus consensus: revenue $36.19M vs $35.40M (+$0.79M, +2.2%), EPS $(2.46) vs $(3.48) (+$1.02); prior quarters showed mixed revenue (misses) but consistent EPS beats as losses narrowed*.
  • Consensus depth is limited (3 estimates for revenue and EPS each), which can amplify beat/miss optics; improved non-GAAP margins and lower cash burn guidance suggest potential upward revisions to loss and margin trajectories*.
MetricQ1 2025Q2 2025Q3 2025
Revenue Consensus Mean ($USD Millions)*$35.20$36.90$35.40
Actual Revenue ($USD Millions)$31.84 $35.54 $36.19
Primary EPS Consensus Mean ($USD)*$(3.99)$(3.64)$(3.48)
Actual EPS ($USD)$(3.10) $(3.18) $(2.46)
# of Estimates (Rev/EPS)*3 / 33 / 33 / 3

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Stronger unit growth and efficiency drove a meaningful EPS beat; watch ASPs as promotions and pricing elasticity support volumes but can pressure margins .
  • Clinical narrative is improving materially (PPV 61.6%, specificity 99.6% in PATHFINDER 2; SYMPLIFY PPV 84.2%), supporting regulatory credibility and payer dialogue .
  • PMA timeline moved up to Q1 2026; near-term catalysts include PMA submission and NHS-Galleri final readout mid-2026—key potential stock drivers .
  • Liquidity de-risked with $325M private placement and planned $110M Samsung investment; runway “into 2030” enables sustained execution and commercialization push .
  • Guidance tightening (FY25 cash burn ≤$290M; U.S. Galleri growth midpoint) signals discipline; non-GAAP margins trending favorably as platform scales .
  • International optionality (Samsung LOI) and Canada launch broaden TAM; initial volumes outside U.S. minimal today but likely to build post-agreements .
  • Near-term trading: emphasize regulatory and evidence cadence, margin trajectory, and pricing/ASP signals; medium-term thesis hinges on PMA approval, reimbursement, and scaling fixed-cost leverage .