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PULSE BIOSCIENCES, INC. (PLSE)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 marked PLSE’s first commercial revenue with $0.086M as Vibrance thyroid procedures began limited release; GAAP net loss was $19.4M and cash fell to $95.2M amid clinical ramp-up .
  • Versus S&P Global consensus, revenue missed ($0.086M vs $0.500M*) while EPS modestly beat (-$0.29 vs -$0.31*); estimate coverage was thin (1 estimate each*) .
  • Management expects procedure volumes to grow in Q4, disposables and system sales to increase, and cash burn to rise as NANOCLAMP AF and 360 Catheter IDE studies scale .
  • Near-term stock catalysts: additional U.S. surgical sites for NANOCLAMP AF (Q4/Q1), EP IDE commencement (Q1), and new safety/efficacy data including 1-year follow-ups on the 360 Catheter at a scientific meeting in Q1 .

What Went Well and What Went Wrong

What Went Well

  • Initial commercialization: PLSE recognized $86K revenue from nPulse capital and Vibrance disposables as limited market release began, validating early commercial demand .
  • Clinical progress in AF surgery: FDA IDE approved for NANOCLAMP AF; first U.S. patient enrolled; EU feasibility showed durable PVI/posterior box isolation with ~50 seconds total ablation time and no ablation-related severe AEs .
  • Soft tissue traction: Over 200 thyroid nodule patients treated across pilot, PRECISE BTN, and initial commercial procedures; one physician reached double-digit monthly volumes, with positive reimbursement trends .

What Went Wrong

  • Revenue below consensus: Q3 revenue of $0.086M was below the $0.500M* consensus, reflecting pilot/evaluation mix and limited recognition rules in early commercialization .
  • Operating expense intensity: GAAP costs/expenses rose to $20.5M (non-GAAP $14.6M), driven by clinical and commercialization build-out and $5.6M stock-based comp; cash used in ops increased to $13.0M .
  • Revenue still nascent: A large portion of procedures are under pilot or PRECISE study and not included in revenue totals, delaying the revenue ramp despite rising utilization .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.000 $0.000 $0.000 $0.086
Net Loss per Share (EPS, $)$(0.21) $(0.25) $(0.28) $(0.29)
GAAP Costs & Expenses ($M)$13.655 $18.044 $20.275 $20.453
Non-GAAP Costs & Expenses ($M)$10.379 $12.671 $14.813 $14.580
GAAP Net Loss ($M)$(12.680) $(16.795) $(19.168) $(19.385)
Non-GAAP Net Loss ($M)$(9.404) $(11.422) $(13.706) $(13.512)
Cash & Equivalents ($M)$79.0 $119.3 $106.3 $95.2
Operating Cash Flow (Used) ($M)$(9.0) $(13.5) $(12.8) $(13.0)

Q3 2025 vs Estimates:

MetricActual Q3 2025Consensus Q3 2025
Revenue ($USD Millions)$0.086 $0.500*
EPS ($)$(0.29) $(0.31)*
EBITDA ($M)$(20.111)*N/A

Values marked with * retrieved from S&P Global.

KPIs and Program Metrics:

KPIQ1 2025Q2 2025Q3 2025
Thyroid patients treated (cumulative)100–130 (initial feasibility and pilot references) >140 >200
PRECISE BTN enrollmentPlanned start Q3 IRB approvals targeted ~40% enrolled
EU surgical AF feasibility—patients treated~30 approved expansion 40 44
EU surgical AF feasibility—remapping at ~3 monthsN/AN/A27 patients remapped
EU surgical AF initial ablation timeN/A~5 sec per application (device-level comment) ~50 sec total per patient
EU 360 Catheter feasibility—patients treated100 >140 150
First U.S. NANOCLAMP AF enrollmentN/AN/AFirst U.S. patient enrolled
Reimbursement trend (thyroid)N/APositive claims processing noted Positive trend continues

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Procedure volumes (thyroid)Q4 2025Pilot expansion; initial commercial in 2H25 Expect procedures to grow in Q4 Raised/affirmed trajectory
Revenue drivers (disposables/system)Q4 2025–2026Initial revenue in 2H25 Sales to grow with acceptance; many procedures not yet revenue Maintained near-term ramp
Operating cash useBack half 2025Burn to tick up in 2H25 Quarterly cash use to increase with trials Maintained/increased
NANOCLAMP AF (surgical) IDEQ4 2025–Q1 2026IDE approval “in next few months” IDE approved; expand sites by YE and into Q1 Achieved; expanding
360 Catheter IDE (EP)Q1 2026 (company release says Q1 2026)Commence “next few months” Resolve open items; commence study in Q1 Timed to Q1 start
Data disclosure (EP catheter)Q1 2026N/ANew safety/efficacy incl. 1-year data expected at scientific mtg in Q1 New catalyst added

Earnings Call Themes & Trends

TopicQ1 2025Q2 2025Q3 2025Trend
Technology differentiation (nsPFA vs microsecond PFA/thermal)Emphasized deeper, faster lesions; lower energy Efficiency gains; reduced stimulation Reinforced across soft tissue and cardiac; branding shift to M‑Pulse/Vibrance Improving awareness
Regulatory progressPreparing IDEs for clamp/catheter IDE submissions made; TAP program benefits Surgical IDE approved/enrollment begun; EP IDE nearing Q1 Advancing
Clinical adoption (soft tissue thyroid)Pilot building; ASC/OR site-of-care shaping >140 treated; reimbursement processing positive >200 treated; early revenues; utilization growing Scaling gradually
Reimbursement/macroReimbursement guidance refined; ASC benefits Positive claims processing noted Positive trend continued Improving
Partnership strategy (EP)Considering strategic partnerActively in discussions; compatibility with CARTO/EnSite demonstrated Partnership remains a focus; could manifest pre-approval Ongoing
Procedure efficiencyInitial catheter data presented; dwell/fluoro times EP ablations as low as 5–8 minutes; skin-to-skin ~45 min Surgical ablations ~50 sec per patient total; durable isolation Strong efficiency narrative
Supply chain/tariffs/macroNot discussedNot discussedNot discussedStable (N/A)
R&D executionFeasibility expansions; focal catheter preclinical data Trial starts imminent EU cohorts enlarged; U.S. IDE surgical started Advancing

Management Commentary

  • “Total revenue was $86 thousand for the third quarter of 2025, including both nPulse capital and Vybrance disposables sales.”
  • “Over 200 patients have now been treated across the pilot program, the PRECISE BTN study, and our first commercial procedures.”
  • “We are pleased to announce that the FDA has granted approval of our IDE pivotal study…The first patient has successfully been enrolled and treated in the IDE study.”
  • “In Europe, our ongoing feasibility study with the 360 Catheter has now enrolled 150 patients…we are anticipating sharing new safety and efficacy data, including one-year follow-up data…in Q1.”
  • “We expect disposables and N‑Pulse system sales will grow…At this time, a large portion of procedures are being completed under our pilot program or as part of the PRECISE study, which are not included in revenue totals.”
  • Physician quote: “I have treated 15 symptomatic thyroid nodule patients, and it is the safest intervention I perform…We are seeing early and significant symptomatic relief in all patients…” —Dr. Richard Harding .

Q&A Highlights

  • Surgical lesion set and stroke adjudication: Lesion set tailored to AF burden; LAA occlusion not part of protocol; strokes adjudicated per norm .
  • EP pivotal funding: Base case is PLSE funds study; partnerships may assist (e.g., mapping support) without core study funding; funding flows through PLSE income statement .
  • PRECISE BTN endpoints: Composite endpoints emphasizing quality of life, symptom burden, and volume reduction to reflect thyroid-preserving benefits beyond raw size reduction .
  • Prior quarter clarifications: EP mapping system compatibility (CARTO/EnSite), ASC suitability given low neuromuscular stimulation and speed; partnership discussions ongoing .

Estimates Context

  • Q3 revenue missed: Actual $0.086M vs $0.500M* consensus; coverage: 1 estimate* .
  • Q3 EPS beat: Actual -$0.29 vs -$0.31* consensus; coverage: 1 estimate* .
  • EBITDA context: S&P Global shows EBITDA actual ~-$20.1M* for Q3, broadly consistent with early-stage operating intensity; prior quarters ~-$20.0M* (Q2) and ~-$17.8M* (Q1).
    Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Early commercialization is underway but revenue recognition is modest and uneven; expect gradual ramp as pilot/evaluation procedures convert to revenue and disposables utilization scales .
  • Clinical/regulatory momentum is strong: surgical IDE active with first U.S. enrollment and EU feasibility durability data; EP IDE targeted to commence in Q1 with 1-year data readout pending—key stock catalysts in the next quarter .
  • Expense and cash burn will rise near term as pivotal trials and commercialization investments expand; watch quarterly cash use trajectory and non-GAAP OpEx discipline .
  • Thyroid soft tissue opportunity shows product-market fit with improving reimbursement; tracking utilization per account is critical to forecasting disposables revenue growth .
  • Partnership potential in EP remains a medium-term lever for market access and commercialization efficiency; monitor announcements for mapping/system integrations and any economics .
  • Estimates likely need recalibration given nascent revenue and thin coverage; EPS beat was optical given limited consensus, while revenue miss reflects early ramp dynamics. Values retrieved from S&P Global.
  • Trading implications: near-term moves likely linked to regulatory and clinical milestones (site expansions, IDE start, 1-year data); medium-term thesis hinges on reproducible clinical efficiency, payer acceptance, and converting pilot sites into high-utilization commercial accounts .