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PULSE BIOSCIENCES, INC. (PLSE)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 results reflected execution on clinical and regulatory priorities: PLSE submitted IDEs for both the cardiac surgical clamp and 360° catheter, expanded the soft tissue ablation pilot (benign thyroid nodules), and continued generating positive feasibility outcomes in Europe .
  • Financially, GAAP net loss widened to $19.2M and diluted EPS to $(0.28), driven by higher G&A and stock-based compensation as PLSE scaled for IDEs and commercialization; cash and equivalents were $106.3M, with operating cash use of $12.8M .
  • Versus S&P Global consensus, PLSE’s Q2 EPS of $(0.28) modestly missed the $(0.26)* consensus; revenue remained $0, in line with a $0* consensus, as initial commercialization is slated for 2H 2025 .
  • Near-term catalysts: IDE approvals and trial starts (clamp and catheter), initial revenue from the Percutaneous Electrode with varied purchase/placement models, and continued European data/readouts (including anticipated publications) .

What Went Well and What Went Wrong

What Went Well

  • Submitted IDEs for both the cardiac surgical clamp and 360° catheter, remaining on track to commence pivotal studies in the next few months, advancing regulatory timelines .
  • Expanded soft tissue ablation pilot; over 140 benign thyroid nodule patients treated to date across multiple centers, with five sites identified for a post-market study expected to begin enrollment in Q3 pending IRB approvals .
  • Management highlighted improving procedure efficiency in catheter ablation with ablation times now as low as 5–8 minutes and skin-to-skin times ~45 minutes, underscoring potential workflow advantages, especially in ASC settings .
    “These achievements further reinforce the transformational potential of nsPFA energy for treating benign thyroid disease, AF and additional diseases in the future.” – CEO Paul LaViolette .

What Went Wrong

  • Operating expenses rose meaningfully year over year as PLSE built commercial and clinical infrastructure; GAAP costs and expenses increased to $20.3M vs. $11.7M in Q2 2024, with stock-based compensation of $5.2M .
  • GAAP net loss widened to $(19.2)M vs. $(11.4)M in Q2 2024; non-GAAP net loss also increased to $(13.7)M vs. $(9.0)M .
  • Cash used in operating activities increased year over year to $12.8M from $8.4M; management guided quarterly cash use higher in the back half to support IDEs and commercialization .

Financial Results

Income Statement Highlights vs Prior Periods and Estimates

MetricQ2 2024Q1 2025Q2 2025Consensus (Q2 2025)
Revenue ($USD)$0 $0 $0 $0*
GAAP Net Loss ($USD Millions)$(11.383) $(16.795) $(19.168) N/A
Diluted EPS ($USD)$(0.20) $(0.25) $(0.28) $(0.26)*

Values with asterisks are retrieved from S&P Global.

Operating Expense Mix and Stock-Based Compensation

Metric ($USD Millions)Q2 2024Q1 2025Q2 2025
Research & Development$7.230 $10.313 $12.088
General & Administrative$4.496 $7.731 $8.187
Stock-Based Compensation$2.052 $5.681 $5.189

Liquidity and Cash Flow

MetricQ2 2024Q1 2025Q2 2025
Cash & Equivalents ($USD Millions)$26.2 $119.3 $106.3
Cash Used in Operating Activities ($USD Millions)$8.4 $13.5 $12.8
Interest Income ($USD Millions)$0.343 $1.249 $1.107

Non-GAAP Reconciliations

Metric ($USD Millions)Q2 2024Q1 2025Q2 2025
Non-GAAP Cost & Expenses$9.376 $12.671 $14.813
Non-GAAP Net Loss$(9.033) $(11.422) $(13.706)

KPIs and Program Metrics

KPIQ4 2024Q1 2025Q2 2025
Thyroid Nodules Treated (Percutaneous Electrode)N/AN/A140+ patients
Cardiac Surgical Clamp – Feasibility Patients Treated30 Protocol expanded beyond initial 30 40
360° Catheter – Feasibility Patients Treated80+ 100 140+
Post-Market Thyroid Study Sites IdentifiedN/APlanned U.S. trial mid-2025 5 sites; enrollment expected Q3 pending IRB
Catheter Ablation Time (procedure)N/APresented strong efficiency at HRS 2025 5–8 min ablations; ~45 min skin-to-skin in recent cases

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Percutaneous Electrode Commercialization2H 2025Launch expected in 2H 2025 Initial revenue in 2H 2025 with varied purchase/placement models; rev rec may be point-in-time or over evaluation period Maintained; added recognition detail
Cardiac Surgical Clamp IDE Pivotal TrialNext few months (2025)On track to receive IDE approval and commence pivotal mid-2025 IDE submitted; on track to commence pivotal in next few months Progressed (milestone achieved)
360° Catheter IDE Pivotal TrialNext few months (2025)Expected to commence U.S. IDE pivotal in mid-2025 IDE submitted; on track to commence in next few months Progressed (milestone achieved)
Operating Cash Use2H 2025N/AQuarterly cash use expected to increase to support IDEs and commercialization Raised cash use outlook
R&D Spend2H 2025N/AR&D spend to increase as IDEs commence and headcount ramps Raised
Post-Market Thyroid StudyQ3 2025U.S. clinical trial expected mid-2025 5 sites identified; enrollment expected to commence in Q3 pending IRB approvals Scheduled (specific sites/timing)
EP Strategic Partnership2025N/APursuing partnership with market leader; potential alignment before or during clinical stage New disclosure

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Soft Tissue Ablation CommercializationBuilt direct commercial team; pilot centers to begin use Pilot expanded; 140+ thyroid patients treated; 5 sites for post-market study; initial revenue expected in 2H Accelerating adoption
Surgical Clamp IDE & Breakthrough/TAPBreakthrough designation; TAP participation; pivotal targeted mid-2025 IDE submitted; trial design up to ~150 patients/~20 sites; first patients expected in next few months Regulatory progress
360° Catheter IDE & Procedure EfficiencyHRS data showed efficiency; 100 patients treated IDE submitted; >140 patients treated; ablation 5–8 min; streamlined workflow Improved performance
Mapping System Compatibility (EP)N/ADemonstrated live-case compatibility with market-leading systems; integration can tighten over time Strengthening ecosystem
ASC Opportunity (EP)N/AManagement emphasized suitability (rapid procedures, low neuromuscular stimulation) Positive positioning
Cash Burn & OpExQ4/Q1 cash use increased with scale Guided higher cash use and R&D spend in 2H to fund IDEs/commercialization Investment ramp

Management Commentary

  • “We have expanded the pilot program for the Percutaneous Electrode… submitted our IDE for both the cardiac surgical clamp and nsPFA 360° catheter, all while continuing to treat more patients and generate positive clinical outcomes… These achievements further reinforce the transformational potential of nsPFA…” – Paul LaViolette, CEO .
  • “We expect quarterly cash use to increase as we invest further in our commercial infrastructure and in our IDE clinical studies… On track… we also expect to generate our initial revenue from the percutaneous electrode in the second half of the year.” – Jon Skinner, CFO .
  • “We are seeing… as low as forty five minute skin to skin times, ablation times consistently below ten minutes… We think our system… could be very well suited for the ASC.” – CEO commentary on EP ablation .

Q&A Highlights

  • Adoption drivers for thyroid ablation: management detailed symptomatic patient characteristics, limitations of thyroidectomy and thermal RFA, and nsPFA’s non-thermal, minimally invasive alternative with symptom relief in ~30 days, aiming to convert surgeries and expand interventions among watchful-waiting patients .
  • Trial design/labeling: catheter ablation trial expected single-arm; surgical clamp pursuing a direct cardiac indication with PMA (Class III) rather than soft tissue .
  • EP partnerships: PLSE is in partnership discussions with market leaders; mapping system compatibility demonstrated via live cases; integration can deepen .
  • European data utilization: human feasibility data for clamp (~40) and catheter (>100) included in IDEs; additional publications expected (e.g., EACTS meeting for clamp) .
  • P&L outlook: R&D and operating cash use to increase in 2H with IDE starts and commercialization ramp .

Estimates Context

  • Q2 2025 EPS actual $(0.28) vs Wall Street consensus $(0.26)* → modest miss driven by elevated G&A and stock-based comp to support scaling and trials .
  • Q2 2025 revenue $0 vs Wall Street consensus $0* → in line; initial commercialization revenue expected in 2H 2025 .

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory milestones gained momentum: dual IDE submissions (clamp and catheter) and expected trial starts in coming months underpin near-term catalysts .
  • Soft tissue (thyroid) traction is building: 140+ patients treated, 5-site post-market study, and initial 2H revenue outlook with flexible commercial models; monitor revenue recognition timing .
  • Operating investment will rise near term: management guided higher R&D and cash burn as trials/commercialization scale; liquidity remains strong at $106.3M .
  • EP catheter efficiency and ASC suitability could be a differentiator vs microsecond PFA, potentially enabling faster procedures and broader venue adoption .
  • Watch for partnership updates in EP: strategic alignment with market leaders may accelerate market access and integration with mapping ecosystems .
  • Non-GAAP adjustments are substantial (stock-based comp, D&A, legal settlement); monitor GAAP-to-non-GAAP deltas when assessing trajectory .
  • Near-term stock drivers: IDE approvals/enrollment pace, initial revenue prints from Percutaneous Electrode, and European data publications (particularly for clamp) .