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CI

CapsoVision, Inc (CV)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered 19% YoY revenue growth to $3.538M, but revenue was below Wall Street consensus ($3.684M), and diluted EPS of $(0.17) missed the $(0.125) consensus; gross margin was 54% vs. 55% in Q2 and 56% in Q3 2024 . Revenue Consensus Mean: $3.684M*; Primary EPS Consensus Mean: $(0.125)*. Values retrieved from S&P Global.
  • Management advanced strategic catalysts: submitted Breakthrough Device Designation (BDD) application to FDA for pancreatic screening (Nov 6), progressed CapsoCam Colon Gen-1 (under review) and began Gen-2 pivotal enrollment; AI module submission for CapsoCam Plus now targeted by year-end 2025 due to biostat resource constraints .
  • Operating expenses rose to $9.933M, including a one-time $1.6M Canon CMOS development charge; CFO clarified this should be removed from forward R&D run-rate .
  • Commercial KPIs strengthened: ~8,336 patients in Q3 (+20% YoY), new accounts +31% YoY, hospital systems customers +26% YoY; U.S. salesforce at 26 reps and 7 managers/trainers .
  • Near-term stock narrative hinges on regulatory milestones (BDD decision, AI module clearance timeline, Colon program progress) and execution on commercial momentum despite near-term margin and OpEx pressure .

What Went Well and What Went Wrong

What Went Well

  • 19% YoY revenue growth to $3.538M, driven by higher CapsoCam Plus capsule sales; gross profit rose to $1.914M .
  • Strategic pipeline progress: FDA BDD application submitted for pancreatic cancer screening; Colon Gen-1 under review; Gen-2 pivotal enrollment started with enhanced optics/AI .
  • Commercial traction: ~8,336 patients in Q3 (+20% YoY), new accounts +31% YoY, hospital systems customers +26% YoY; management emphasized cloud-based workflow and in-house AI competency as differentiators .

Selected management quotes:

  • “We delivered a strong third quarter… submission for Breakthrough Device Designation… underscores our commitment…” .
  • “We currently plan to submit… AI… to the FDA by year-end 2025… slight delay due to resource constraints…” .
  • “Our Gen-1… is currently under FDA review, and we have begun enrolling patients in our pivotal study for the Gen-2 capsule… submission in Q2 2026… clearance in Q4 2026” .

What Went Wrong

  • Revenue missed consensus by ~$0.145M (−3.9%) and diluted EPS missed by $0.045; gross margin compressed to 54% vs. 55% in Q2 and 56% YoY . Revenue Consensus Mean: $3.684M*; Primary EPS Consensus Mean: $(0.125)*. Values retrieved from S&P Global.
  • Operating expenses increased to $9.933M, including $1.6M R&D tied to Canon CMOS development; net loss widened to $(7.921) vs. $(5.794) YoY .
  • AI module submission timing slipped from late Sep/early Oct to year-end 2025 due to biostatistician constraints, shifting anticipated commercialization to second half next year .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Revenue ($USD Millions)$2.966 $3.315 $3.538
Gross Profit ($USD Millions)$1.657 $1.811 $1.914
Gross Margin %56% 55% 54%
Total Operating Expenses ($USD Millions)$7.460 $6.462 $9.933
Operating Loss ($USD Millions)$(5.803) $(4.651) $(8.019)
Net Loss ($USD Millions)$(5.794) $(4.625) $(7.921)
Diluted EPS ($USD)$(2.79) $(2.02) $(0.17)
Cash and Equivalents ($USD Millions)$9.799 $1.066 $17.787

Estimates vs. Actuals

MetricQ2 2025 ConsensusQ2 2025 ActualQ3 2025 ConsensusQ3 2025 Actual
Revenue ($USD Millions)$3.2465*$3.315 $3.6835*$3.538
Primary EPS ($USD)$(0.11)*$(2.02) $(0.125)*$(0.17)

Values retrieved from S&P Global.

KPIs

KPIQ3 2024Q2 2025Q3 2025
Patients in quarter (approx)6,961 ~7,900 ~8,336
Cumulative patients (as of period end)N/A>143,000 >151,000
New accounts growth YoYN/A+75% +31%
GI clinics/mega GI groups growth YoYN/A+46% +24%
Hospital systems customers growth YoYN/A+35% +26%
U.S. sales repsN/A25 26
Regional managers/trainers (U.S.)N/A7 7
U.S. patentsN/A82 82
Reimbursement codeCPT 91110 CPT 91110 CPT 91110

Notes: Q1 2025 documents were not available in the document set; prior period trend comparisons use Q2 2025 and Q3 2024 where relevant.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CapsoCam Plus AI module – FDA submissionQ4 2025Late Sep/early Oct 2025 submission By year-end 2025; slight delay due to biostat constraints Lowered (timing delayed)
CapsoCam Plus AI – commercialization2026“Plan to launch next year” FDA review ~3–6 months; “should be available in the second half” Lowered (shift to 2H 2026)
CapsoCam Colon Gen-12025510(k) submitted Jun 2025 Under FDA review Maintained
CapsoCam Colon Gen-22026Submit in 2026 Pivotal enrollment underway; submit Q2 2026; potential clearance Q4 2026 Clarified timeline
Pancreatic screening – BDD submissionQ4 2025Plan to submit by year-end Submitted Nov 6, 2025 Raised (achieved submission)
R&D expense run-rate2025 onwardN/A$1.6M Canon-related R&D in Q3 was one-time; remove for forward run-rate Lower underlying run-rate
Sales headcount plan202625 reps; scale over time Maintain 26 reps; add two territories in 2026 (FL, NY metro) Modest expansion planned
Revenue cadenceH2 2025H2 > H1; Q3 stronger; Q4 seasonally highest Not updated numerically in Q3; qualitative cadence maintained Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2025)Current Period (Q3 2025)Trend
AI-enabled diagnosticsSubmit AI module late Sep/early Oct; launch next year Submission by year-end 2025; review 3–6 months; availability in 2H next year Delayed timing
CapsoCam Colon program510(k) Gen-1 submitted; plan Gen-2 submission in 2026 Gen-1 under FDA review; Gen-2 pivotal enrollment; submit Q2 2026; clearance Q4 2026 Progressing
Pancreatic screening (BDD)Plan to submit BDD by year-end BDD application submitted Nov 6, 2025 Advancing
Commercial tractionNew accounts +75%; hospital systems +35% Patients ~8,336; new accounts +31%; hospital systems +26% Sustained growth
Sales headcount25 reps; 7 managers/trainers 26 reps; maintain; add two territories in 2026 Stable, modest add
R&D spendClinical spend decreased; overall OpEx $6.5M OpEx $9.933M; includes one-time $1.6M Canon R&D Elevated by one-time
Cloud/data & reimbursementCloud-based workflow; CPT 91110 Continued emphasis on cloud; CPT 91110 Maintained

Management Commentary

  • “We delivered a strong third quarter… submission for Breakthrough Device Designation… underscores our commitment…” — Johnny Wang, CEO .
  • “We currently plan to submit… AI… to the FDA by year-end 2025… slight delay… due to resource constraints from our third-party biostatisticians.” — Johnny Wang .
  • “Our Gen-1… is currently under FDA review, and we have begun enrolling patients in our pivotal study for the Gen-2 capsule… submit in Q2 2026… potential clearance in Q4 2026.” — Johnny Wang .
  • “Net loss was $7.9 million… We ended the quarter with $17.8 million in cash and equivalents… R&D expenses for [Canon]… were $1.6 million.” — David Garcia, SVP Finance .
  • “Think of [the $1.6M Canon R&D] as one-time in nature for Q3. Going forward, you can take that out.” — David Garcia .

Q&A Highlights

  • AI module timing: FDA submission shifted to year-end 2025; expected 3–6 month review with market availability in 2H next year .
  • R&D expense normalization: $1.6M Canon-related R&D in Q3 is one-time; remove from forward run-rate .
  • Pancreatic feasibility: Prior small study (~20 subjects) observed both cancers present (2/2), informing pursuit of BDD and pivotal strategy .
  • Imaging sensor roadmap: Pancreas pivotal to proceed with Toshiba sensor + new optics; Canon CMOS expected 2026 readiness, integrating in 2027 products .
  • Salesforce: Maintain 26 territory managers and 7 managers/trainers; add two U.S. territories in 2026 (Florida, NY metro) .

Estimates Context

  • Q3 2025: Revenue $3.538M vs consensus $3.6835M* (miss), EPS $(0.17) vs $(0.125)* (miss). Hinted drivers include margin compression (54%) and elevated OpEx tied to R&D and public company costs .
  • Q2 2025: Revenue $3.315M vs $3.2465M* (beat); EPS $(2.02) vs $(0.11)* (miss), noting unusual comparability due to pre-IPO share base .
  • Forward revisions likely to incorporate delayed AI module submission and 2H 2026 commercialization, and normalized R&D spend post-Canon one-time .

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Revenue growth remained robust (+19% YoY), but Q3 was a modest revenue and EPS miss versus consensus amid gross margin compression and one-time R&D costs; watch for margin recovery and OpEx normalization post-Canon charge .
  • Regulatory catalysts are central to the near-term narrative: BDD submission for pancreatic screening completed; AI module submission now year-end; Colon Gen-1 review and Gen-2 pivotal/clearance milestones in 2026 .
  • Commercial KPIs strengthen the base: increased patients, new accounts, and hospital adoption, supported by cloud-based workflow and CPT 91110 reimbursement .
  • Cash position improved to $17.8M following IPO, providing runway to fund clinical and regulatory programs; monitor cash burn normalization as one-time R&D rolls off .
  • Expect estimate adjustments: consensus likely to push out AI-driven revenue inflection to 2H 2026 and reflect gross margin trajectory and OpEx mix; any BDD progress could be a positive sentiment catalyst .
  • Execution risks include regulatory timelines (FDA review), sensor integration path (Canon CMOS cadence), and maintaining growth while controlling OpEx as a new public company .
  • Trading lens: stock likely sensitive to FDA updates (AI module, Colon, BDD), evidence of margin stabilization, and sequential revenue cadence into seasonally strong Q4 .