Sign in
CL

Caris Life Sciences, Inc. (CAI)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered a material beat and inflection to profitability: revenue $216.83M (+113% y/y) and diluted EPS $0.08, with gross margin at 68.0% and Adjusted EBITDA $51.17M; management highlighted a $37.9M revenue true-up and underlying gross margin ~61% ex true-ups .
  • Wall Street consensus for Q3: revenue ~$174.22M and EPS -$0.136; actuals were a significant beat on both, and EBITDA materially exceeded consensus as well (see Estimates Context) [*].
  • Guidance raised: FY25 revenue to $720–$730M (from $675–$685M) and clinical therapy selection volume growth to 21–22%; management also pointed to Q4 revenue of $200–$210M and mid-60s gross margin, with Q4 OpEx in the “higher $120M” range .
  • Key drivers: strong clinical ASPs (total ASP $4,089 vs $3,256 in Q2), continued volume growth (50,763 cases), Caris Assure blood adoption (7,537 cases; 40% attachment to tissue), and lab efficiency (TAT: tissue 8 days, blood 7 days) .
  • Catalysts into Q4–2026: expected pharma R&D revenue step-up in Q4 ($20–$30M), progress on MRD reimbursement (CRC submission underway), early detection readouts (Achieve One 1H26) and potential LDT launch, and New York State approval for blood assay in process .

What Went Well and What Went Wrong

What Went Well

  • Profitable quarter and strong operating leverage: gross margin expanded to 68.0% (+2,432 bps y/y), Adjusted EBITDA $51.17M, net income $24.33M; “We delivered another record quarter… achieving positive net income” — CEO David D. Halbert .
  • ASP strength and reimbursement progress: total ASP rose to $4,089; management noted “stronger-than-expected collections… resulted in a $37.9M revenue true-up” and base tissue ASP reached ~$3,500, with Q4 base guide ~$3,600; goal >$4,000 in 1H26 — CFO Luke Power .
  • Pipeline momentum: MRD colorectal data showed 96.3% PPA and 100% NPA vs a third-party assay; early detection studies (Achieve One complete enrollment; Achieve Two >15,600 enrolled) and incorporation of whole genome; “We’ll read out Achieve One in the first half of next year” — President David Spetzler .

What Went Wrong

  • True-up dependence and underlying margins: excluding the Q3 true-up, underlying gross margin was ~61%, highlighting reliance on collections catch-ups; management emphasized they do not forecast true-ups .
  • Pharma R&D sequential softness in Q3: revenue declined sequentially with projects shifting into Q4; guide implies $20–$30M in Q4, underscoring lumpiness and timing risk .
  • OpEx expected higher in Q4: management flagged Q4 OpEx in the “higher $120M” range due to investment in early detection and commercial readiness, moderating near-term margin trajectory despite profitability .

Financial Results

Consolidated P&L and Cash Metrics (oldest → newest)

MetricQ3 2024Q2 2025Q3 2025
Total Revenue ($M)$101.62 $181.40 $216.83
Gross Margin (%)43.7% 62.7% 68.0%
Operating Expenses ($M)$105.25 $131.67 $114.86
Operating Income (Loss) ($M)$(60.84) $(17.99) $32.64
Net Income (Loss) ($M)$(67.73) $(71.79) $24.33
Diluted EPS ($)$(2.59) $(7.97) $0.08
Adjusted EBITDA ($M)$(45.59) $16.71 $51.17
Free Cash Flow ($M)$(71.26) $5.90 $55.33
Net Cash from Ops ($M)$(69.43) $7.29 $62.43

Segment Revenue Breakdown ($M)

SegmentQ3 2024Q2 2025Q3 2025
Molecular Profiling Services$93.80 $162.92 $207.59
Pharma R&D Services$7.82 $18.47 $9.25

KPIs: Volume, ASP, Efficiency

KPIQ3 2024Q2 2025Q3 2025
Total Clinical Case Volume42,956 50,032 50,763
MI Profile (Tissue) Volume38,409 42,886 43,226
Caris Assure (Blood) Volume4,547 7,146 7,537
Total Clinical ASP ($)2,184 3,256 4,089
MI Profile ASP ($)2,241 3,379 4,273
Assure ASP ($)1,697 2,519 3,034
TAT (Tissue/Blood, days)8 / 7
Blood-Tissue Attachment Rate~35% ~40%
Covered Lives (MI Cancer Seek)~170M (incl. Medicare) >200M

vs Estimates (Q3 2025)

MetricConsensusActualSurprise
Revenue ($M)174.22*216.83 Beat
Primary EPS ($)-0.136*0.08 Beat
EBITDA ($M)7.20*37.51*Beat

Values retrieved from S&P Global.*

Notes: Adjusted EBITDA per company was $51.17M; SPGI’s EBITDA “actual” reflects their standard definition, not company-adjusted .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025$675–$685M $720–$730M Raised
Clinical Therapy Selection Volume GrowthFY 202519–21% 21–22% Raised
Q4 Total RevenueQ4 2025$200–$210M (management assumption) New detail
Gross Margin (Full Year)FY 2025~60% (goal) ~62% (updated view) Raised
OpExQ4 2025$115–$120M per quarter (2H25) “Higher $120M” in Q4 Raised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
ASP/ReimbursementQ2: Tissue ASP $3,256; Medicare catch-ups; commercial covered lives ~170M; ASP guided to rise; true-ups included Base tissue ASP ~$3,500; Q4 base ~$3,600; >200M covered lives; $37.9M true-up; goal >$4,000 in 1H26 Improving ASP trajectory; strong payer adoption
Gross Margin/ProfitabilityQ2: 62.7% GM; Adjusted EBITDA positive; FY GM goal ~60% 68.0% GM; ~61% ex true-up; FY GM ~62%; net income positive Structural margin expansion with operating leverage
Caris Assure (Blood) AdoptionQ2: 7,146 cases; ~35% attachment; NY State approval pending 7,537 cases; 40% attachment; blood ASP $2,377 base; Q4 guide $2,300–$2,400 Steady adoption, rising attachment, ASP gains
MRD (CRC) and ReimbursementQ2: submission plan to MolDX; initial data sets, broader study pipeline MRD CRC shows 96.3% PPA/100% NPA; submission data ready; commercialization can leverage existing channel Advancing validation; poised for coverage dialogue
Early DetectionQ2: strategy to start with breast; strong initial performance; self-pay launch contemplated Achieve One complete; Achieve Two >15.6k enrolled; adding whole genome; readout 1H26; LDT launch considered before Achieve Two readout Scaling clinical studies; nearer-term LDT path
Pharma R&DQ2: +49% y/y; pipeline more weighted to Q4 Q3 sequential dip; Q4 guide $20–$30M; focus on multi-year data partnerships and CDx Timing-driven; expecting Q4 step-up
New York State Approval (Blood)Q2: pending, catalyst for volume Reiterated as a volume catalyst Still pending; potential upside

Q-1 column is N/A due to lack of public Q1 earnings call/press release found.

Management Commentary

  • CEO vision: “We delivered another record quarter for revenue and clinical volume, achieving positive net income… toward delivering the next generation of personalized solutions through our exciting pipeline in MRD and early detection” — David D. Halbert .
  • CFO on true-ups and ASP trajectory: “Stronger-than-expected collections… resulted in a $37.9M revenue true-up… base tissue ASP ~$3,500 in Q3… we still expect Q4 base ASP… around $3,600… goal… above $4,000 ASP for tissue” — Luke Power .
  • President on MRD data: “We demonstrated 96.3% PPA and 100% NPA… the separation with p<0.005 supports the test’s ability to accurately distinguish recurrence risk” — David Spetzler .
  • Efficiency gains: “Turnaround time for tissue down to eight days and blood at seven days… demonstrates significant progress on lab efficiencies” — Luke Power .
  • Strategic posture: “We’re not going above 30% adjusted EBITDA… we want to reinvest… early detection… MRD” — Luke Power .

Q&A Highlights

  • ASP and margins ex true-ups: Management does not forecast true-ups; underlying Q3 gross margin ~61% excluding true-up, indicating strong core profitability trend .
  • MRD commercialization: Existing oncology sales force can scale MRD without material headcount expansion; pricing discussions with MolDX expected, not price-sensitive initially .
  • Early detection cadence and LDT: Achieve One readout 1H26; LDT launch considered before Achieve Two readout; whole genome backbone added for early detection .
  • Pharma R&D outlook: Q4 revenue guide implies a sizable step-up ($20–$30M), with emphasis on long-term data partnerships and CDx; timing drives quarterly lumpiness .
  • OpEx investment: Q4 OpEx guided to “higher $120M” to support pipeline and commercial readiness, balancing reinvestment with sustained profitability .
  • Blood attachment and NY approval: Blood attachment rose to ~40% (from ~35% in Q2); NY State approval remains a key catalyst to expand volumes .

Estimates Context

  • Q3 2025 consensus vs actuals: revenue ~$174.22M vs actual $216.83M; EPS -$0.136 vs actual $0.08; EBITDA ~$7.20M vs actual ~$37.51M — material beats on all three. Expect upward revisions to FY25 revenue and EPS following the guidance raise and profitability inflection [*].
  • FY25 trajectory: With full-year revenue guidance raised to $720–$730M and gross margin now expected at ~62%, consensus likely to recalibrate higher on revenue, margins, and EPS; Q4 pharma step-up and ASP resilience are supportive .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Caris is transitioning to profitable growth with structural margin expansion (68% GM; ~61% ex true-ups), supported by ASP gains and lab efficiency; maintain focus on recurring ASP sustainability and payer mix .
  • Guidance raise to $720–$730M FY25 and volume growth 21–22% increases confidence in 2H momentum; Q4 setup includes pharma R&D step-up and continued clinical ASP strength .
  • Blood adoption is building with rising attachment rates and ASP; pending NY State approval is a tangible near-term catalyst for incremental volume .
  • MRD CRC data are compelling (96.3% PPA; 100% NPA), positioning for coverage progress; commercialization can leverage the existing channel without major opex burden .
  • Early detection program is scaling with whole genome integration; Achieve One readout in 1H26 and potential LDT launch could open a premium self-pay revenue stream .
  • Watch for normalization of true-up impacts and base margin trajectory; management does not forecast true-ups, suggesting cleaner comps into 2026 .
  • Trading lens: near-term upside catalysts include Q4 delivery vs the $200–$210M revenue view, pharma contribution ($20–$30M), and any updates on MRD coverage/NY approval; medium-term thesis hinges on sustained ASP/margin expansion and pipeline conversion.

Citations: Q3 8-K/press release ; Q3 call transcript ; Q2 8-K/press release and call ; Additional relevant press releases .