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PULSE BIOSCIENCES, INC. (PLSE)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 remained pre-revenue with GAAP net loss of $19.4M and EPS of $(0.31), as operating expenses ramped to support clinical programs and commercialization; cash rose to $118.0M on Q4 warrant exercises (+$39.0M QoQ), extending runway .
  • Management advanced three nsPFA programs: soft tissue ablation (8 U.S. pilot centers, commercial use expected in “the next several months”), cardiac surgical clamp (30 patients treated; IDE submission mid-2025), and 360° catheter (over 80 patients treated; U.S. IDE pivotal “middle of 2025”) .
  • Non-GAAP net loss improved vs GAAP given exclusions (stock comp, D&A, severance, legal settlement), with Q4 non-GAAP net loss of $10.4M and non-GAAP opex of $11.3M .
  • No formal financial guidance or quarterly Wall Street consensus; FY 2025 S&P Global displays limited coverage (EPS, revenue, target price), implying estimates may need to reflect later-than-revenue commercialization milestones and opex intensity; stock narrative is driven by clinical/regulatory catalysts rather than near-term earnings beats/misses .*

What Went Well and What Went Wrong

What Went Well

  • Clinically, nsPFA platform momentum: benign thyroid feasibility showed nodule volume reductions averaging >50% with early symptom relief, and U.S. pilot program expanded to 8 centers with expected commercial conversion in coming months .
  • AF programs progressed: surgical clamp treated 30 patients across multiple European sites; 360° catheter surpassed 80 patients with 100% acute conduction block in the initial cohort and additional data slated for HRS in Q2 2025 .
  • Balance sheet strengthened: $47.9M raised via warrant exercises in Q4, lifting cash to $118.0M at year-end, supporting IDE pivotal studies and early commercialization .

Management quotes:

  • “Nanosecond PFA will be a disruptive and transformative technology in multiple clinical applications and in large markets.” — CEO Paul LaViolette .
  • “Top priorities for 2025 are to advance commercialization of soft tissue ablation in the thyroid market and to initiate IDE pivotal studies for our Cardiac 360 catheter and cardiac surgical clamp.” — CEO Paul LaViolette .

What Went Wrong

  • Expense growth and dilution: GAAP costs rose to $20.3M (+$7.7M YoY) driven by higher stock-based comp, compensation, severance, and legal settlement; GAAP net loss widened to $(19.4)M .
  • Still pre-revenue: product revenues remained $0; operating losses reflect development-stage profile and lack of commercial revenue contribution in Q4 .
  • Quarterly cash burn ticked up to $9.3M vs $8.5M in Q3, reflecting scaling costs ahead of pivotal trials and commercialization .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$0.0 $0.0 $0.0
GAAP Costs & Expenses ($USD Millions)$11.726 $13.655 $20.261
Non-GAAP Costs & Expenses ($USD Millions)$9.376 $10.380 $11.286
GAAP Net Loss ($USD Millions)$(11.383) $(12.680) $(19.385)
Non-GAAP Net Loss ($USD Millions)$(9.033) $(9.405) $(10.410)
Basic & Diluted EPS ($USD)$(0.20) $(0.21) $(0.31)
Cash & Cash Equivalents ($USD Millions)$26.2 $79.0 $118.0
Cash Used in Quarter ($USD Millions)$8.7 $8.5 $9.3

EBITDA (actuals)

MetricQ2 2024Q3 2024Q4 2024
EBITDA ($USD Millions)$(11.43)*$(13.36)*$(19.97)*

Values retrieved from S&P Global.*

Segment breakdown: Not applicable (no revenue reported) .

KPIs

KPIQ2 2024Q3 2024Q4 2024
U.S. pilot centers (soft tissue)5 7 8
Surgical clamp patients treated (cumulative)2 9 30
360° catheter patients treated (cumulative)30+ (expanded to 60) >50 >80
Acute PV conduction block success (initial cohort)——100%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Soft tissue ablation U.S. commercial use timingNear-term“Commercial use expected to begin in coming quarters” (Q3) “Expected to begin commercial use over the next several months” (Q4) Raised clarity/sooner
Percutaneous Electrode Benign Thyroid pivotal/IDE startMid-2025“Commence pivotal trial mid-2025” (Q3) “Commence U.S. clinical trial in mid-2025” (Q4) Maintained
Cardiac Surgical Clamp IDE submission & pivotal startMid-2025“Submit IDE and commence pivotal in mid-2025” (Q3) “Expects to submit IDE; commence pivotal mid-2025” (Q4) Maintained
360° Catheter U.S. IDE pivotal startMid-2025“Begin U.S. IDE pivotal in middle of 2025” (Q3) “Commence U.S. IDE pivotal sometime in the middle of 2025” (Q4) Maintained
Financial guidance (revenue/margins/OpEx)FY 2025NoneNoneN/A

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024 and Q3 2024)Current Period (Q4 2024)Trend
Soft tissue ablation commercializationFirst U.S. cases; 5 pilot sites; planning pivotal benign thyroid trial in 1H25 8 pilot centers; commercial conversion expected “over next several months” Accelerating
Surgical clamp (AF)First 2 patients in EU; Breakthrough + TAP; PMA pathway; pivotal design near-term 30 patients treated; JTCVS preclinical publication; IDE submission mid-2025 Building evidence; regulatory progress
360° catheter (AF)Expanded to 60 patients; added EU sites; planning U.S. IDE pivotal mid-2025 >80 patients; 100% acute conduction block; HRS data in Q2 2025; U.S. IDE pivotal mid-2025 Strong adoption; study expansion
RegulatoryTAP engagement; Breakthrough for surgical clamp; PMA strategy IDE submissions targeted mid-2025 for clamp and catheter Advancing toward pivotal
FinancingRights offering gross $60M; potential $66M via warrants $47.9M warrant exercises in Q4; cash $118.0M Strengthened
Reimbursement—Pathway to favorable reimbursement for thyroid procedure discussed Emerging narrative

Management Commentary

  • “Our top priorities for the year are to advance commercialization of our soft tissue ablation device in the thyroid market and to initiate IDE pivotal studies for our Cardiac 360 catheter and cardiac surgical clamp.” — CEO Paul LaViolette .
  • “Late-breaking data… demonstrated that 100% of lesions were acutely successful in conduction block.” — CEO Paul LaViolette .
  • “The data presented on 30 patients… achieved on average 83% volume reduction at 1 year and significant reductions in symptoms just 1 month after treatment.” — CEO Paul LaViolette (thyroid cohort) .
  • “GAAP costs and expenses were $20.3M… driven by noncash stock-based compensation of $6.8M along with other compensation… severance and legal settlement.” — CFO Jon Skinner .

Q&A Highlights

  • The Q4 call did not feature an analyst Q&A; prepared remarks focused on program updates, cost drivers, and financing progress .
  • Management reiterated commercialization timeline (soft tissue) and mid-2025 pivotal timelines (clamp, catheter) without quantitative guidance updates .

Estimates Context

  • Quarterly consensus (EPS, revenue) was not available for Q4 2024; PLSE remains pre-revenue and not broadly covered for near-term quarterly forecasts. FY 2025 S&P Global consensus shows EPS of -$1.14*, Revenue of ~$0.34M*, and a Target Price consensus of $22*, with no published consensus recommendation text. Values retrieved from S&P Global.*
  • Implication: As clinical catalysts dominate, sell-side estimates likely focus on operating cash burn and milestone timing rather than near-term revenue/EPS beats.

Estimates (where available)

MetricPeriodConsensusActual
EPS ($USD)FY 2025$(1.14)*N/A (future)
Revenue ($USD)FY 2025$0.336M*N/A (future)
Target Price ($USD)FY 2024/FY 2025$22.00*$22.00*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Cash runway strengthened: year-end cash of $118.0M, supported by $47.9M Q4 warrant exercises, positions PLSE to fund mid-2025 IDE pivotal starts and early commercialization; monitor additional warrant exercises/redemptions as secondary catalysts .
  • Near-term commercial catalyst: soft tissue ablation program expected to shift select U.S. pilot centers to paid commercial use in “the next several months,” offering first directional revenue signals and adoption KPIs; watch site conversions and installed base growth .
  • Clinical readouts: 360° catheter HRS Q2 2025 and surgical clamp preliminary data late-2025 are key efficacy/efficiency inflection points to de-risk PMA strategies and frame competitive positioning vs microsecond PFA incumbents .
  • Expense trajectory: opex growth reflects scaling for pivotal trials and commercialization; track non-GAAP opex progression and stock-based comp levels to assess burn-rate normalization post-pivotal initiation .
  • Regulatory milestones: execution on IDE submissions (mid-2025) across clamp and catheter is central to valuation; TAP/Breakthrough engagement should facilitate timelines .
  • Revenue modeling: with FY 2025 consensus minimal and pre-revenue status, base cases should weight clinical/regulatory probabilities and commercial adoption velocity over near-term P&L beats; target price consensus ($22*) implies event-driven narrative. Values retrieved from S&P Global.*
  • Trading implication: stock likely reacts to data disclosures (HRS), IDE submissions, and evidence of commercial traction in thyroid ablation; upside tied to nsPFA differentiation vs microsecond PFA and speed of converting pilots to paying sites .