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PULSE BIOSCIENCES, INC. (PLSE)·Q1 2025 Earnings Summary

Executive Summary

  • Pre-revenue quarter with accelerated operating spend to support clinical and commercialization milestones: GAAP operating expenses rose to $18.0M (+69% YoY), GAAP net loss was $16.8M (vs. $10.1M YoY), and EPS was $(0.25) (vs. $(0.18) YoY) .
  • Liquidity remained strong: cash and cash equivalents were $119.3M at March 31, 2025 (vs. $118.0M at 12/31/24 and $34.9M at 3/31/24), aided by $14.1M of warrant exercises in Q1 .
  • Clinical execution advanced across three devices: 100 European AF patients treated with the nsPFA 360° catheter and strong early durability (94.2% PV isolation; 95.5% posterior wall), EU IRB expanded surgical clamp feasibility to 60 patients, and >90 U.S. patients treated in soft tissue pilot; commercial launch of the percutaneous electrode targeted for H2 2025 .
  • No Wall Street consensus available for Q1 2025 EPS or revenue via S&P Global; management reiterated H2 2025 initial revenue expectations tied to soft tissue commercialization, and IDE pivotal trial starts in mid-2025 for the 360 catheter and surgical clamp .

What Went Well and What Went Wrong

What Went Well

  • Device-level clinical momentum: “Clinical data on the catheter-based treatment of AF with the nsPFA 360° catheter were presented at the Heart Rhythm Society 2025 Meeting, demonstrating excellent procedure efficiency and acute outcomes” .
  • Strong durability signals: 3‑month invasive remapping showed durable PV isolation in 81/86 veins (94.2%) and posterior wall isolation in 21/22 patients (95.5%), supporting the IDE path for the 360 catheter in mid‑2025 .
  • Balance sheet flexibility maintained: Cash ended Q1 at $119.3M, with $14.1M raised through warrant exercises, preserving year‑end levels for clinical scale-up and commercialization .

What Went Wrong

  • Elevated operating costs: GAAP costs/expenses rose to $18.0M (from $10.6M YoY) driven by stock-based compensation ($5.7M vs. $1.8M YoY) and expansion ahead of pivotal trials and launch .
  • Higher cash burn: Cash used in operating activities increased to $13.5M in Q1 (vs. $9.8M YoY and $9.1M in Q4 2024), underscoring pre‑revenue investment intensity .
  • No revenue yet: Product revenues remained $0 (as in Q4 and Q3 2024), pushing all profitability metrics deeper negative and delaying revenue-based validation until H2 2025 .

Financial Results

Income Statement vs Prior Quarters (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Total Revenues ($USD)$0 $0 $0
Total Cost and Expenses ($USD)$13.655M $20.261M $18.044M
Net Loss ($USD)$(12.680)M $(19.385)M $(16.795)M
Basic & Diluted EPS ($USD)$(0.21) $(0.31) $(0.25)

Q1 2025 vs Q1 2024 (YoY)

MetricQ1 2024Q1 2025
Total Revenues ($USD)$0 $0
Total Cost and Expenses ($USD)$10.615M $18.044M
Net Loss ($USD)$(10.137)M $(16.795)M
Basic & Diluted EPS ($USD)$(0.18) $(0.25)
Interest Income ($USD)$0.478M $1.249M

Liquidity & Cash Flow

MetricQ3 2024Q4 2024Q1 2025
Cash & Cash Equivalents ($USD)$79.033M $118.038M $119.279M
Cash Used in Operating Activities ($USD)$8.5M $9.1M $13.5M
Weighted Avg Shares (basic/diluted)61.066M 62.056M 67.126M

Non-GAAP Results (Q1)

MetricQ1 2024Q1 2025
Non-GAAP Cost & Expenses ($USD)$8.556M $12.671M
Non-GAAP Net Loss ($USD)$(8.078)M $(11.422)M
Stock-Based Compensation ($USD)$1.759M $5.681M

Operational KPIs

KPIQ3 2024Q4 2024Q1 2025
Soft Tissue Pilot – U.S. sites/patients7 sites placed 8 centers planned >90 patients treated in pilot
Surgical Clamp – EU feasibility patients9 patients 30 treated EU IRB expanded to 60 patients
360° Catheter – EU feasibility patients>50 >80 100 total treated
360° Catheter – 3‑mo durability (PV/PW)——94.2% PV, 95.5% PW success

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Percutaneous Electrode – U.S. commercial launchH2 2025“Commercial use expected to begin in the coming quarters” (Q3 2024) “Launch … expected in the second half of 2025” (Q1 2025) Clarified timing (maintained trajectory)
Percutaneous Electrode – U.S. clinical trial start (benign thyroid nodules)Mid‑2025“Expects to commence … in mid‑2025” (Q4 2024) “Expects to commence … in mid‑2025” (Q1 2025) Maintained
Cardiac Surgical Clamp – IDE pivotal trial startMid‑2025“Expects to submit IDE enabling pivotal trial in mid‑2025” (Q4 2024) “Remaining on track to receive IDE approval to commence pivotal trial in mid‑2025” (Q1 2025) Maintained/advanced
360° Catheter – IDE pivotal trial startMid‑2025“Expects to commence U.S. IDE pivotal clinical study mid‑2025” (Q4 2024) “Expects to commence a U.S. IDE pivotal clinical study sometime in the middle of 2025” (Q1 2025) Maintained
Initial Revenue (soft tissue)H2 2025“Commercial use expected over next several months” (Q4 2024) “Plans to generate revenue … expected to materialize in the second half” (Q1 2025) Clarified timing to H2 2025

Earnings Call Themes & Trends

TopicQ3 2024 (Oct)Q4 2024 (Mar)Q1 2025 (May)Trend
nsPFA platform positioningIntroduced next‑gen nano‑PFA thesis and multi‑indication strategy Reinforced platform/clearances and breakthrough/TAP status “Mounting clinical evidence” across three devices Strengthening narrative
Soft tissue ablation commercialization7 U.S. pilot sites; expand pilot into 2025 8 centers expected to begin commercial use next months Over 90 patients in pilot; launch H2 2025 Execution toward launch
Surgical clamp feasibility9 patients; EU multicenter plan 30 treated; third EU site; breakthrough/TAP reiterated EU IRB expansion to 60; mid‑2025 pivotal IDE on track Scaling trial sites
360 catheter feasibility & durability>50 patients treated; strong acute isolation >80 patients; late‑breaking data planned 100 patients; 3‑mo durability 94.2% PV/95.5% PW Robust clinical signals

Management Commentary

  • “We are pleased to be generating mounting clinical evidence that confirms the tremendous benefits of our nsPFA technology across each of our three devices.” — Paul LaViolette, CEO .
  • “This early clinical work has positioned us favorably to initiate our IDE pivotal trial to support FDA approval of the nanosecond PFA 360 cardiac catheter system in the middle of the year.” — Paul LaViolette .
  • “Non-GAAP costs and expenses … increased by $4.1 million to $12.7 million … GAAP net loss … was $16.8 million … cash and cash equivalents totaled $119.3 million … more than offset by $14.1 million in proceeds from the exercise of warrants.” — Jon Skinner, CFO .

Q&A Highlights

  • The Q1 2025 call did not include an analyst Q&A session; the operator closed the call without questions .
  • Management reiterated IDE timelines and H2 2025 commercialization steps within prepared remarks .

Estimates Context

  • No Wall Street consensus available via S&P Global for Q1 2025 EPS or revenue; results therefore cannot be benchmarked to consensus for this quarter [GetEstimates: Q1 2025 empty].
  • Current forward consensus (limited coverage) suggests ongoing losses and small initial revenues as commercialization begins:
MetricQ3 2025Q4 2025Q1 2026Q2 2026
Primary EPS Consensus Mean ($USD)-0.31*-0.32*-0.37*-0.42*
Revenue Consensus Mean ($USD)$0.50M*$0.25M*$0.50M*$0.75M*

Values retrieved from S&P Global.*

Implications: As PLSE transitions from pre‑revenue to initial commercialization in H2 2025, estimate revisions will likely hinge on cadence of system placements, utilization in soft tissue, and clarity on pivotal trial progress for AF devices.

Key Takeaways for Investors

  • Pre‑revenue profile persists with an H2 2025 launch path for soft tissue ablation; initial revenue depends on installed base and procedural adoption in benign thyroid nodules .
  • Clinical de‑risking for AF: strong early durability and efficiency metrics for the 360 catheter improve visibility into mid‑2025 IDE pivotal initiation and eventual PMA route .
  • Cash runway supported by warrant exercises; liquidity of $119.3M should fund pivotal studies and commercial build‑out, though operating cash burn rose to $13.5M in Q1 .
  • Expense intensity reflects stock‑based comp and scaling; monitor normalized opex (non‑GAAP cost/expenses) which rose to $12.7M in Q1 .
  • Near‑term trading catalysts: HRS/AF Symposium data dissemination, IDE approvals/starts (mid‑2025), and U.S. launch milestones for the percutaneous electrode .
  • Medium‑term thesis: Platform optionality across soft tissue and AF, with differentiated nsPFA mechanism offering potential safety/efficacy advantages; value inflection with pivotal data and early commercialization execution .
  • Watch for reimbursement clarity and workflow best practices in thyroid nodules to accelerate adoption and revenue conversion in H2 2025 .