Pulse Biosciences, Inc. (PLSE) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlights strong strategic developments, including a new partnership in cardiac ablation and compatibility with major mapping systems. Despite increased expenses and net losses, the company maintains a solid cash position, indicating disciplined financial management. The positive aspects, such as the partnership and product compatibility, outweigh the negatives, suggesting a likely positive stock reaction.
Key Financial Performance
Total GAAP costs and expenses (Q2 2025) $20.3 million, an increase of $8.5 million year-over-year. The increase was primarily driven by administrative expenses related to the expanding organization to support advancement of nsPFA device clinical trials and commercialization, along with other compensation and noncash stock-based compensation.
Non-GAAP costs and expenses (Q2 2025) $14.8 million, an increase of $5.4 million year-over-year. This excludes stock-based compensation and depreciation and amortization.
GAAP net loss (Q2 2025) $19.2 million, compared to $11.4 million in the prior year period. The increase in net loss reflects higher costs and expenses.
Non-GAAP net loss (Q2 2025) $13.7 million, compared to $9 million in the prior year period. This excludes stock-based compensation and depreciation and amortization.
Cash and cash equivalents (as of June 30, 2025) $106.3 million, compared to $26.2 million as of June 30, 2024. The increase reflects disciplined expense management and planned cash usage.
Cash used in operating activities (Q2 2025) $12.8 million, compared to $8.4 million in the prior year period. The increase is aligned with planned cash usage and investments in commercial infrastructure and IDE clinical studies.
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Operating Highlights
nsPFA technology: Developed a next-generation energy modality for therapeutic ablations with shorter pulse durations, reducing thermal damage.
Percutaneous Electrode System: FDA-cleared for soft tissue ablation, targeting benign thyroid nodules. Over 140 patients treated in pilot program with positive outcomes. Transitioning procedures to ambulatory surgery centers or operating rooms for better patient access and reimbursement.
Cardiac Surgical Clamp: Received FDA Breakthrough Device designation. IDE submission under review for a clinical trial involving 150 patients across 20 sites. Positive feasibility study results in Europe with 40 patients treated.
360 Catheter System: Feasibility study ongoing in Europe with over 140 patients treated. IDE submission under review for atrial fibrillation treatment. Positive outcomes reported, including reduced procedure times and improved lesion consistency.
Soft Tissue Ablation Market: Targeting a large U.S. market for benign thyroid nodules, with potential to convert thyroidectomy operations to minimally invasive procedures.
Electrophysiology Ablation Market: Exploring strategic partnerships with market leaders to expand adoption of nsPFA technology.
Clinical Data Generation: Conducting multicenter prospective clinical studies and presenting findings at major conferences to drive awareness and adoption.
Commercial Infrastructure: Investing in infrastructure to support IDE clinical studies and commercialization of nsPFA devices.
Regulatory Approvals: Advancing IDE submissions for multiple devices to achieve regulatory milestones.
Strategic Partnerships: Exploring collaborations with market leaders in electrophysiology to enhance market positioning.
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Risk or Challenges
Regulatory Hurdles: The company is awaiting FDA approval for its IDE submissions for the cardiac surgical clamp and 360 catheter system. Delays or rejections in these approvals could impact the timeline for clinical trials and market entry.
Financial Risks: The company reported a GAAP net loss of $19.2 million in Q2 2025, an increase from $11.4 million in the prior year. Cash use is expected to increase further due to investments in commercial infrastructure and clinical studies, which could strain financial resources.
Market Adoption Challenges: The adoption of the nsPFA technology depends on generating high-quality clinical data and convincing clinicians to transition from existing methods. The sales cycle for capital equipment is lengthy, and initial revenue generation is dependent on pilot programs and customer contracts.
Operational Risks: The company is transitioning procedures to ambulatory surgery centers (ASC) or operating rooms (OR), which may require additional logistical and operational adjustments. This shift could also impact patient access and reimbursement processes.
Competitive Pressures: The company faces competition from existing ablation technologies, including microsecond PFA and thermal ablation methods. Convincing clinicians and patients of the advantages of nsPFA over established methods is critical for market penetration.
Clinical Trial Risks: The success of ongoing and future clinical trials in Europe and the U.S. is crucial for regulatory approvals and market adoption. Any negative outcomes or delays in these trials could adversely affect the company's strategic objectives.
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Guidance & Outlook
Revenue Expectations: The company expects to generate its initial revenue from the percutaneous electrode in the second half of 2025. Revenue recognition will depend on individual contracts with commercial pilot program participants and new customers, with potential deferral of revenue based on specific agreements.
Market Potential and Growth Expectations: The nsPFA percutaneous electrode system is expected to address unmet clinical needs in the treatment of benign thyroid nodules, with a market potential of several hundred thousand patients per year in the U.S. alone. The company anticipates an expansion in interventional volume for benign thyroid nodule treatment by offering nsPFA as a minimally invasive option.
Clinical Trials and Regulatory Progress: The company plans to commence a multicenter prospective clinical study for the nsPFA percutaneous electrode system in Q3 2025, with enrollment starting upon IRB approvals. For the cardiac surgical clamp, the IDE submission is under review, and the clinical trial is expected to enroll up to 150 patients across 20 sites, with enrollment anticipated to begin in the next few months. The 360 catheter system IDE study is also expected to commence in the next few months.
Strategic Partnerships: The company is exploring strategic partnerships in the electrophysiology space to enhance market adoption and create value for stakeholders.
Capital Expenditures and Cash Use: Quarterly cash use is expected to increase as the company invests in commercial infrastructure and IDE clinical studies for cardiac devices. These investments align with the company's 2025 priorities.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What are the patient baseline characteristics driving the pull-through for nsPFA in thyroid ablation?
A:Patients are symptomatic with thyroid nodules that grow due to hormonal changes or immune diseases, causing pressure in the neck area, encroaching on the trachea and esophagus, and altering thyroid function. These nodules can also cause discomfort, disrupt sleep, and become unsightly. The current treatment options, such as thyroidectomy, are undesirable as they result in the loss of thyroid function. nsPFA offers a less invasive alternative that preserves thyroid function, provides symptomatic relief within 30 days, and avoids surgery.
Q:What is the expectation for the catheter ablation study and the surgical AF ablation IDE label?
A:The catheter ablation study is expected to be a single-arm study in EP. For the surgical AF ablation IDE, the label will be for cardiac ablation, not soft tissue ablation, as the goal is to pursue a direct cardiac indication with PMA.
Q:Is Pulse collaborating with a market leader in cardiac ablation, and are there any details on the partnership?
A:Yes, Pulse is collaborating with a market leader in cardiac ablation. However, no additional details were shared other than the strategy to pursue partnerships for catheter-based EP due to competitive and cost dynamics. A partnership is expected to align with the commercial timeline or possibly during the clinical stage.
Q:What is the compatibility of the nsPFA platform with mapping systems like Abbott's and Biosense Webster's CARTO 3?
A:The nsPFA platform is compatible with both Abbott's and Biosense Webster's CARTO 3 mapping systems. Live cases have demonstrated compatibility, and integration can become tighter over time depending on collaboration with the partners.
Q:How is nsPFA positioned for the ASC opportunity, and what are its advantages?
A:nsPFA is well-suited for ASCs due to its ability to enable rapid procedures, low neuromuscular stimulation, and effective ablation. Recent cases in Europe showed 45-minute skin-to-skin times and ablation times consistently below 10 minutes. These factors, along with reduced anesthesia requirements, make it advantageous for ASCs.
Q:Will the data from overseas studies for cardiac clamp and catheter be published, and how will it play into the PMA application?
A:Yes, the data from overseas studies will be published. For the cardiac clamp, additional data publications and case demonstrations are expected at the EACTS meeting in October. The data from both studies will be included in the respective IDE submissions and will help demonstrate safety and effectiveness to the FDA.
Q:Will the PMA submissions for the clamp and catheter be modular, and how does breakthrough designation impact the timeline?
A:Yes, the PMA submissions for the clamp and catheter will be modular, which allows for a more efficient review process. Breakthrough designation and participation in the TAP program have been helpful in improving regulatory timing and transparency.
Q:What is the expected R&D demand and operating cash burn for the second half of the year?
A:R&D demand is expected to increase in the second half of the year due to the commencement of two clinical trials for IDEs and associated headcount growth. Operating cash burn is also expected to increase from $12.8 million in Q2 as the company hires more staff and begins initial commercialization activities for the percutaneous electrode.
Q:Review of Unclear Management Responses
A:Management avoided providing specific details about the partnership with the market leader in cardiac ablation, stating only that discussions are ongoing and a partnership is expected to align with the commercial timeline or clinical stage.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Ablation
Annual Meeting
CEO Principal
Energy
Europe catheter
Financial Officer
IDE approval
LLC
Officer President
Officer Principal
President CEO
Principal Executive
Principal Financial
Research Division
ablation time
adoption ablation
awareness
catheter IDE
center
clamp
cycle
device ablation
device feasibility
electrophysiology
freedom
guideline
minute
pilot launch
procedure practice
sale
setting
study Europe
submission review
surgeon experience
surgery patient
trial patient
value
volume
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