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HeartSciences Inc. (HSCS)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 FY2025 delivered no revenue and deeper losses as development spending continued; cash fell to $2.6M from $4.1M in Q2 and $4.3M in Q1, and shareholders’ equity declined to $1.8M .
  • EPS of -$2.57* missed Wall Street consensus of -$2.305* (miss of -$0.27*) and EBITDA of -$2.37M* missed consensus of -$2.05M* (miss of -$0.32M*) as the company remains pre-commercial; revenue was $0 vs. consensus $0 .
  • Regulatory milestones progressed: MyoVista wavECG final FDA pre-sub meeting occurred in Feb-2025; management now anticipates FDA submission in 1H 2025 (vs. Q1 target earlier), and Phase 1 of MyoVista Insights was completed in Dec-2024 .
  • CMS included HeartSciences’ AI-ECG algorithms in the 2025 OPPS final rule effective Jan-2025, enabling reimbursement at commercial launch—a potential stock reaction catalyst when regulatory clearances are achieved .

Values retrieved from S&P Global.*

What Went Well and What Went Wrong

What Went Well

  • “This quarter has seen considerable across the board progress… clinical validation for the MyoVista wavECG device is expected within weeks and… FDA submission would follow… in the first half of the year.” — CEO Andrew Simpson .
  • Phase 1 of MyoVista Insights (cloud-native ECG reporting) was completed on schedule in Dec-2024; early deployment test discussions underway .
  • CMS OPPS 2025 final rule included HeartSciences’ AI-ECG algorithms, enabling appropriate reimbursement upon commercial launch, de-risking post-clearance monetization .

What Went Wrong

  • No revenue and negative EBITDA/earnings persisted as the company remains pre-commercial; cash declined to $2.6M and equity to $1.8M, increasing financing needs .
  • FDA submission timing for MyoVista wavECG shifted from “around end of Q1 2025” to “1H 2025,” indicating minor delay to near-term regulatory timeline .
  • Limited analyst coverage and small-cap profile reflected in minimal consensus estimates; earnings and EBITDA missed consensus, likely due to higher development and validation costs than expected.*

Values retrieved from S&P Global.*

Financial Results

Income Statement and EPS (Quarterly)

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD)$0.015M $0.000M $0.000M $0.000M
Net Income ($USD)-$1.64M*-$2.05M*-$2.08M*-$2.54M*
Diluted EPS (Cont. Ops) ($USD)-$3.01*-$2.64*-$2.27*-$2.57*
EBITDA ($USD)-$1.52M*-$2.06M*-$1.97M*-$2.37M*

Values retrieved from S&P Global.*

Liquidity and Equity (Quarterly)

MetricQ1 2025Q2 2025Q3 2025
Cash and Equivalents ($USD)$4.30M $4.10M $2.60M
Total Equity ($USD)$5.90M $4.00M $1.80M
Cash from Operations ($USD)-$2.02M*-$2.18M*-$1.62M*

Values retrieved from S&P Global.*

Actual vs. Consensus (Q3 FY2025)

MetricActualConsensusSurprise
Revenue ($USD)$0.000M $0.000M*$0.000M*
Diluted EPS ($USD)-$2.57*-$2.305*-$0.265*
EBITDA ($USD)-$2.37M*-$2.05M*-$0.32M*
# of Estimates (EPS/Revenue)—2 / 2*—

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
MyoVista wavECG FDA 510(k) submissionCalendar 2025“Around end of Q1 2025” “Submit for clearance within 1H 2025” Lowered/Delayed
MyoVista Insights Phase 1 completionCalendar 2024“Complete by end of 2024” “Completed in Dec-2024; test deployments in 2025” Achieved/Completed
MyoVista Insights Phase 2 (adds AI-ECG reporting)Calendar 2025“Aiming for regulatory clearance in 2H 2025” “Aiming for regulatory submission in 2H 2025” Maintained
First cloud-based AI-ECG algorithm (LVEF ≤40) submissionCalendar 2025Pre-validation to begin; FDA studies to follow Pre-validation with Rutgers completed; target FDA submission 2H 2025 Raised (progressed)
Reimbursement (CMS OPPS)Effective Jan-2025Inclusion proposed in OPPS final ruleConfirmed inclusion; reimbursement effective Achieved/Confirmed

No financial guidance was provided for revenue, margins, OpEx, OI&E, tax rate, dividends in Q3 materials .

Earnings Call Themes & Trends

No earnings call transcript was available in the filings for Q3 FY2025; themes are derived from press releases and 8-Ks.

TopicPrevious Mentions (Q-2)Previous Mentions (Q-1)Current Period (Q3)Trend
AI/technology initiativesBuilding device + cloud AI-ECG; Phase 1 near completion; “app store” model Cloud + device-based AI-ECG; KOL momentum Phase 1 completed; test sites planned; marketplace vision reiterated Positive execution
Regulatory progress (MyoVista wavECG)Pre-submission meeting requested; submission “around end of Q1 2025” FDA 510(k) “on track Q1 2025” Final pre-sub in Feb-2025; submission targeted 1H 2025 Slight delay but advancing
CMS reimbursementAlgorithms included in OPPS 2025, effective Jan-2025 —Inclusion confirmed; management highlights higher rate vs conventional ECG Regulatory de-risking
Platform phases (Insights)Phase 1 to complete by end-2024; Phase 2 in 2H 2025; Phase 3 ECG management system Phase 1 on track; algorithm pre-validation starting Phase 1 done; Phase 2 aims 2H 2025; Phase 3 vision reiterated On plan
Cash runway/financing$4.1M cash; $4.0M equity $4.3M cash; $5.9M equity; $1.9M non-dilutive financing $2.6M cash; $1.8M equity Deteriorating liquidity
Clinical validation (algorithm)Pre-validation progressing; FDA studies to follow Pre-validation to begin Pre-validation with Rutgers completed; FDA validation next Advancing

Management Commentary

  • “Clinical validation for the MyoVista wavECG device is expected within weeks and… FDA submission would follow… in the first half of the year.” — Andrew Simpson, CEO .
  • “We successfully completed Phase 1 MyoVista Insights cloud-native platform on schedule… pre-validation of the low ejection fraction algorithm… This is the first of several algorithms licensed from… Mount Sinai…” .
  • “CMS has already established reimbursement for AI-ECG at a rate significantly higher than that of conventional ECG… highlights the significant commercial opportunity…” .

Q&A Highlights

  • No Q3 earnings call transcript or Q&A disclosures were found in company filings; guidance clarifications came via press release and 8-K .

Estimates Context

  • Q3 FY2025 EPS of -$2.57* missed consensus -$2.305*; EBITDA of -$2.37M* missed consensus -$2.05M*; revenue was $0 vs. consensus $0 .
  • Coverage depth remained limited (two estimates each for EPS and revenue*), implying potential volatility and need for updates following regulatory milestones.*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Pre-commercial profile drives continued losses; cash of $2.6M and equity of $1.8M highlight near-term financing considerations as the company advances regulatory work .
  • Regulatory catalysts are near: wavECG clinical validation “within weeks” from Feb-2025 and submission targeted for 1H 2025; Insights Phase 2 submission and first cloud algorithm targeted for 2H 2025 .
  • Reimbursement tailwind: CMS OPPS inclusion effective Jan-2025 supports monetization post-clearance and could re-rate the story upon approvals .
  • Expect estimate revisions as timelines shift from Q1 2025 to 1H 2025 for wavECG; development spending likely remains elevated near term.*
  • Commercial strategy spans device and cloud, with an AI-ECG marketplace potentially accelerating adoption across varied care settings .
  • Trading setup: stock may be catalyst-driven; watch for FDA validation/readouts, submission filings, and any capital raises, which could influence liquidity and price direction .

Values retrieved from S&P Global.*

Appendix: Source Documents Read

  • Q3 FY2025 business update and financial results press release (Mar-13-2025) .
  • Q3 FY2025 8-K (Mar-13-2025), including Item 2.02 and Exhibit 99.1 .
  • Prior quarters: Q2 FY2025 8-K and press release (Dec-16-2024) ; Q1 FY2025 8-K and press release (Sep-12-2024) .

Values retrieved from S&P Global.*