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Insight Molecular Diagnostics Inc. (IMDX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered minimal revenue and continued operating losses as IMDX remains essentially pre-revenue pending GraftAssureDx FDA clearance: revenue $0.26M, gross margin 53.5%, net loss -$10.9M, EPS -$0.34; cash, cash equivalents and restricted cash ended at $20.2M .
  • Management reiterated year-end FDA submission timing and mid-2026 commercial launch, noting potential timing risk from the federal government shutdown; Bio-Rad instrumentation and kit lots are in-house and sites are actively enrolling .
  • Favorable head-to-head assay data, growing clinician engagement, and a 5,000-participant registry are expected to drive adoption and validate PPV improvements; Medicare reimbursement for the LDT is $2,753 per result .
  • CFO guided Q4 cash burn temporarily above $6M due to FDA submission/trial costs; Q3 cash burn from operations was $4.6M with $1.1M capex, tracking to ~$6M average quarterly spend .

What Went Well and What Went Wrong

What Went Well

  • On-track FDA submission by year-end 2025; mid-2026 launch plan maintained despite shutdown risk, with multiple clinical sites actively collecting samples and reproducibility workstreams in place .
  • Strong qualitative momentum: favorable head-to-head data vs legacy assays, global pilot adoption, and registry program expected to validate higher PPV and accelerate familiarization with IMDX reports .
  • Clear commercialization framework and TAM math: kit-first, decentralized testing model in a concentrated market with potential industry-leading operating margins; Medicare reimbursement benchmark supports kit ASPs .
    • “The margins available to us in GraftAssure… represent a rare opportunity to create an exceptionally profitable business line with operating margin that should be industry-leading.”

What Went Wrong

  • Sequential revenue decline and margin compression: Q3 revenue fell to $0.26M (from $0.52M in Q2) and gross margin to 53.5% (from 67.6%), reflecting lumpy lab services and pre-FDA kit revenue status .
  • Continued heavy operating expenses tied to submission readiness and non-cash contingent consideration; Q3 net loss -$10.9M, with non-GAAP loss from operations of -$6.6M .
  • Execution risks acknowledged: FDA review timeline subject to shutdown dynamics; sample enrollment “slower than desired”; Q4 burn guided above ~$6M due to FDA/trial costs .

Financial Results

Quarterly P&L and Cash Metrics

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$2.10 $0.518 $0.260
Gross Profit ($USD Millions)$1.33 $0.350 $0.139
Gross Margin %62.0% 67.6% 53.5%
Total Operating Expenses ($USD Millions)—$10.192 $11.187
Loss from Operations ($USD Millions)—-$9.842 -$11.048
Net Loss ($USD Millions)—-$9.742 -$10.854
EPS (Basic/Diluted, $)—-$0.30 -$0.34
Cash, Cash Equivalents & Restricted Cash ($USD Millions)~$33.0 $26.0 $20.2
Cash from Operations ($USD Millions)—-$6.279 -$4.626
Capital Expenditures ($USD Millions)—-$0.349 -$1.050

Revenue Composition

Revenue ComponentQ2 2025 ($USD Millions)Q3 2025 ($USD Millions)
Lab Services$0.494 $0.260 (all revenue derived from lab services)
Kitted Products (RUO)$0.024 $0.000 (no kitted product revenue)
LDT Services$0.000 $0.000

KPIs and Operating Updates

KPIQ1 2025Q2 2025Q3 2025
Gross Margin %62.0% 67.6% 53.5%
Clinical Trial Sites (participating/active)Central IRB approved; sites preparing Listing includes top U.S. centers; public as of Jul 15 11 trial sites; Vanderbilt, Tampa General, Cleveland Clinic actively collecting
Registry Program Scope—Announced planning and design underway 5,000 participants across ~50 centers, ~50,000 samples over up to six years
Medicare Reimbursement (LDT)—$2,753 per result (May 2025) $2,753 per result (benchmark for kit ASP)
Cash Burn Guidance~-$6M/quarter target ~$6M with temporary fluctuations Q3 CFO -$4.626M; Q4 expected above $6M due to FDA/trial

Results vs Wall Street Consensus (S&P Global)

MetricQ3 2025 ConsensusQ3 2025 Actual
Revenue ($USD)$285,000*$260,000
Primary EPS ($)-0.21*-0.34
EBITDA ($USD)-$5,850,000*-$7,086,000*

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FDA Submission TimingFY2025Submit by year-end 2025 On track to submit by year-end 2025; reviewer working despite shutdown Maintained
Launch TimingMid-2026Mid-2026 launch window Mid-2026 launch window reaffirmed; shutdown may affect timing Maintained (risk noted)
Cash Burn (Quarterly)Q2–Q3 2025Target ~$6M with temporary fluctuations Q3 CFO -$4.626M; Q4 expected to tick above ~$6M due to FDA/trial Slightly raised Q4
Reporting Framework2026Non-GAAP operating loss discussed Will introduce Adjusted EBITDA; non-GAAP net income and EPS Expanded metrics
Lab Services RevenueQ4 2025—“Model sequentially flat in Q4”; $100k billed so far New qualitative guide

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025, Q2 2025)Current Period (Q3 2025)Trend
FDA Submission & TimelineFinal pre-submission prep; central IRB approved; target FDA submission by year-end; mid-2026 launch On-track submission by year-end; government shutdown risk acknowledged; reviewers active; mid-2026 launch maintained Steady execution; external timing risk
Head-to-Head/Performance DataRUO kit validation and favorable comparisons vs NGS; growing pilot data Favorable head-to-head vs leading U.S. centralized lab tests; strong PPV narrative via CM score Building scientific case
Registry StrategyRegistry planning mentioned 5,000-participant, ~50 centers, ~50,000 samples; early 2026 customer engagement Scaling clinician engagement
Market Access & ReimbursementMedicare increased LDT reimbursement to $2,753; MolDX draft LCD baseline tests Applying LDT claim in registry; continued MolDX discussion; potential guideline/IOTA tailwinds Positive structural tailwinds
Bio-Rad Partnership & Ease-of-UseBio-Rad workflow benefits for dPCR; ease-of-use vs NGS Instruments shipped; kit lots produced; one-step workflow improvements Operational readiness
Cash Burn & RunwayTarget ~$6M burn; capex for trial instruments; $33M cash including restricted Q3 burn below target due to timing; Q4 above $6M; $20.2M cash, cash equivalents and restricted cash Controlled burn; runway declining pre-FDA
Organ ExpansionPipeline beyond kidney; heart/lung/liver discussion Validations for heart and lung in CLIA lab; reimbursement targets: heart 2026, lung 2027 Expanding scope

Management Commentary

  • “The margins available to us in GraftAssure, along with a highly concentrated market, represent a rare opportunity to create an exceptionally profitable business line with operating margin that should be industry-leading.” — Josh Riggs, CEO
  • “We finished the quarter with $20 million in cash and equivalents and no debt… We kept our cash burn in Q3 below our stated goal of $6 million per quarter, and we expect that $6 million to tick up a bit in Q4 due to expenses associated with our FDA submission and clinical trial.” — Andrea James, CFO
  • “We remain on track to submit GraftAssureDx to the FDA by the end of 2025… We are still preparing for a mid-2026 product launch.” — Shareholder letter/8-K
  • “Our registry… is designed to generate real-world data… validating the clinical utility of our novel combined dd-cfDNA score and assessing the ‘Berlin protocol’ for high-risk patients.” — 8-K
  • “Medicare… improved its reimbursement price for our assay to $2,753 per result… we believe we can sell our kits to hospital customers for a significant fraction of the reimbursed value.” — CFO

Q&A Highlights

  • Reimbursement/LCD/IOTA: Management hopes final MolDX LCD permits clinician-driven testing intervals; IOTA could increase demand by incentivizing use of at-risk organs requiring closer monitoring .
  • LDT Registry/Billing: Registry tied to CLIA lab operations; centers can bill relative dd-cfDNA under current MolDX claim while IMDX provides comparison/novel measures; head-to-head programs subsidized by IMDX per CMS rules .
  • Conversion Curve Post-Clearance: Expect “show-me” adoption with early head-to-head data and registry familiarization; launch framework focuses on engagement/utilization pre-FDA to accelerate slope .
  • FDA Risks/Timeline: Biggest risk is FDA timing under shutdown; team pre-preparing responses to minimize stop-the-clock delays; reviewers engaged through MedUFA funding .
  • Trial Enrollment & Submission Mechanics: Five sites actively enrolling; submission package largely pre-written; final sensitivity/specificity numbers to be plugged in at the end .

Estimates Context

  • Q3 2025 missed on both revenue and EPS vs consensus: revenue $0.260M vs $0.285M*, EPS -$0.34 vs -$0.21*; EBITDA also below consensus (-$7.09M* vs -$5.85M*) as pre-clearance costs persisted .
  • With kit revenue expected post-FDA, near-term estimate revisions likely focus on operating expense cadence, burn trajectory, and timing of registry-driven LDT volumes rather than top-line inflection. Values retrieved from S&P Global.*

Q3 2025 Actual vs Consensus (S&P Global)

MetricConsensusActual
Revenue ($USD)$285,000*$260,000
Primary EPS ($)-0.21*-0.34
EBITDA ($USD)-$5,850,000*-$7,086,000*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Near-term catalyst: year-end FDA submission; mid-2026 commercialization reiterated—watch for any shutdown-related timing updates and additional head-to-head publications .
  • Operating discipline: Q3 burn below ~$6M target due to timing; Q4 burn guided above ~$6M for submission/trial; monitor liquidity and cadence of registry/LDT revenues .
  • Adoption setup: registry program and subsidized head-to-head will drive clinician familiarization and PPV validation, supporting conversion post-clearance in a concentrated market (~100 U.S. centers) .
  • Pricing/ASP backdrop: Medicare LDT reimbursement at $2,753 per result provides a constructive benchmark for kit ASPs in decentralized settings .
  • Scientific differentiation: combined dd-cfDNA score aims to improve PPV and reduce unnecessary biopsies; favorable comparisons vs sequencing-based incumbents support the kit-first thesis .
  • Pipeline expansion: heart and lung validations ongoing with reimbursement submissions targeted for heart in 2026 and lung in 2027, expanding TAM beyond kidney .
  • Risk monitor: FDA process and government funding uncertainties remain the primary exogenous risks; sample enrollment pace and burn trajectory are the key execution variables to track .