[Management View]
Pulse Biosciences reported its first revenues from the nPulse platform and Vibrance disposables during a limited market release. Management emphasized the momentum in pilot and clinical programs, with over 200 procedures completed. The company achieved FDA IDE approval for its NanoClamp AF pivotal study in atrial fibrillation and expanded its cardiac program across Europe with positive interim results.
[Outlook]
The company expects growth in disposables and nPulse system sales as procedure acceptance increases. The PRECISE BTN study aims to complete enrollment in Q1, with outcome data to follow. Management confirmed funding for the pivotal nPulse 360 study from internal resources, with strategic partnerships targeted for commercialization.
[Financial Performance]
Total revenue for Q3 was $86,000. GAAP costs and expenses increased by $6.8 million to $20.5 million, driven by clinical trials and commercialization expenses. Non-GAAP costs rose by $4.2 million to $14.6 million. GAAP net loss was $19.4 million, compared to $12.7 million a year prior. Cash and cash equivalents totaled $95.2 million, up from $79 million in 2024.
[Q&A Highlights]
Question 1: How should we think about the pre-op lesion work set done for NanoClamp? Is left atrial appendage closure part of the trial?
Answer: The lesion set varies based on AFib severity, with surgeon discretion. Left atrial appendage occlusion is not part of the protocol, focusing solely on ablation procedures.
Question 2: Will PULSE fund the NS 360 pivotal trial unilaterally or seek a strategic partner?
Answer: PULSE plans to fund the study, but remains open to partnership strategies, particularly for commercialization. A mapping partner may support procedures, but core study funding will come from PULSE.
Question 3: Can you provide details on the performance criteria for PRECISE BTN?
Answer: The study measures compressive symptom elimination, volume reduction, and quality of life. NSPFA shows faster symptom burden reduction compared to RF, aiming for a composite endpoint to establish new data.
[Sentiment Analysis]
Analysts expressed positive sentiment regarding clinical progress and strategic initiatives. Management maintained a confident tone, emphasizing the disruptive potential of their technology and strategic focus.
[Quarterly Comparison]
| Metric | Q3 2025 | Q3 2024 |
|-------------------------|---------|---------|
| Total Revenue | $86,000 | N/A |
| GAAP Costs & Expenses | $20.5M | $13.7M |
| Non-GAAP Costs & Expenses| $14.6M | $10.4M |
| GAAP Net Loss | $19.4M | $12.7M |
| Cash & Equivalents | $95.2M | $79M |
[Risks and Concerns]
Risks include the reliance on pilot programs for procedure volume, which may not immediately contribute to revenue. The company faces challenges in expanding market access and achieving commercial adoption.
[Final Takeaway]
Pulse Biosciences is at a pivotal stage, having achieved initial revenue and significant regulatory milestones. The company's focus on advancing its clinical programs and strategic partnerships positions it well for future growth. Continued execution of its strategic priorities and successful commercialization of its innovative technologies will be crucial for long-term success.
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