Pulse Biosciences outlines initial percutaneous electrode revenue and IDE milestones while expanding nsPFA clinical programs

Earnings Call Insights: Pulse Biosciences (PLSE) Q2 2025

MANAGEMENT VIEW

* Paul Arthur LaViolette, President and CEO, described the ongoing expansion across three market development programs, emphasizing the clinical and commercial progress with the nsPFA technology: “We have expanded pilot utilization of the percutaneous electrodes for soft tissue ablation initially in benign thyroid disease. We have also submitted our nsPFA 360 catheter IDE to treat atrial fibrillation. So in addition to our previously submitted IDE for the pivotal trial of our cardiac surgical clamp, we are advancing toward our regulatory goals with 2 IDEs under review.”
* LaViolette reported over 140 patients have been treated with the percutaneous electrode in the pilot program, with procedure and site volumes continuing to grow, and highlighted a transition to ambulatory surgery centers or operating rooms as preferred care settings based on provider feedback.
* He stated, “Throughout the second half of 2025, we expect to achieve a blend of nonrevenue evaluation procedures and revenue-generating procedures from our first commercial customers.”
* A multicenter prospective clinical study is set to begin in Q3 2025, with five sites identified and contracted for additional data collection.
* On cardiac programs, the company is progressing with two IDEs under FDA review for the surgical clamp and 360 catheter, reinforcing confidence with ongoing feasibility studies in Europe: “We have 3 centers enrolling patients and have already treated 40 patients. Feedback from surgeons has been positive. Reporting the device consistently produces fast, contiguous and transmural ablation.”
* LaViolette confirmed active pursuit of a strategic partnership for the 360 catheter in the electrophysiology market, stating, “We are focused on the possibilities of collaborating with a market leader in the electrophysiology space to create value for all stakeholders and will provide updates on partnership progress when appropriate.”
* Jon Skinner, CFO, stated, “In the second quarter of 2025, total GAAP costs and expenses increased by $8.5 million to $20.3 million compared to $11.7 million in the prior year period. The increase in GAAP cost and expenses was primarily driven by an increase in administrative expenses related to the expanding organization to support advancement of our nsPFA device clinical trials and commercialization.”
* Skinner added, “As of June 30, 2025, cash and cash equivalents totaled $106.3 million compared to $26.2 million as of June 30, 2024. Cash used in operating activities during the second quarter of 2025 was $12.8 million compared to $8.4 million used in the prior year period and $13.5 million in Q1 of 2025.”

OUTLOOK

* Management reiterated expectations to generate initial revenue from the percutaneous electrode in the second half of the year, noting, “This initial revenue recognition will value based on the individual contracts with commercial pilot program participants and new customers.”
* Skinner noted, “We also expect to generate our initial revenue from the percutaneous electrode in the second half of the year.”
* Investments in commercial infrastructure and IDE clinical studies are expected to increase quarterly cash use in the upcoming quarters.

FINANCIAL RESULTS

* Total GAAP costs and expenses for Q2 2025 were reported as $20.3 million, with non-GAAP costs and expenses at $14.8 million.
* GAAP net loss for the quarter was ($19.2 million), while the non-GAAP net loss was ($13.7 million).
* Cash and cash equivalents at the end of the quarter were $106.3 million, down $12.9 million from Q1 2025.
* Cash used in operating activities in Q2 2025 was $12.8 million, compared to $13.5 million in Q1 2025.

Q&A

* Suraj Kalia, Oppenheimer: Asked about patient baseline characteristics for nsPFA pull-through. Paul LaViolette explained that symptomatic patients with problematic thyroid nodules, often younger and mostly female, have limited good alternatives and that nsPFA offers a minimally invasive, gland-sparing solution without the risks of thermal ablation or thyroidectomy.
* Kalia followed up on study design and labeling for the catheter and clamp. LaViolette confirmed a single-arm study in EP and pursuit of a direct cardiac indication for the clamp.
* Joshua Thomas Jennings, TD Cowen: Queried about partnership strategy for cardiac ablation. LaViolette stated, “No additional details to share today other than reinforcing our strategy…We have determined as it relates to catheter-based EP that a partnership is most appropriate. We're in partnership discussions.”
* Jennings asked about mapping system compatibility. LaViolette confirmed live case demonstrations and compatibility with Abbott and Biosense Webster mapping systems, noting potential for deeper integration depending on collaboration interest.
* Jennings inquired about ASC positioning. LaViolette highlighted procedure efficiency and suitability, referencing, “skin-to-skin times, ablation times consistently below 10 minutes with operators that have just a little bit of case experience.”
* Anthony Charles Petrone, Mizuho: Asked about European data publication and PMA process. LaViolette explained both human datasets are included in IDE submissions and will be shared at upcoming conferences and publications.
* Petrone also asked about R&D spend trends. Skinner responded, “We do expect that to increase throughout the back half of the year…as we again hire more heads to support those 2 IDEs and also the initial commercialization activities.”

SENTIMENT ANALYSIS

* Analysts focused on specifics of clinical adoption drivers, partnership strategy, study designs, and operating expense trends, showing a slightly positive tone and highlighting enthusiasm for clinical progress and commercialization.
* Management maintained a confident and detailed tone in prepared remarks, with LaViolette regularly emphasizing clinical value, regulatory milestones, and commercial readiness. During Q&A, management provided thorough responses and acknowledged strategic uncertainty around partnerships.
* Compared to the previous quarter, the tone remained confident but showed increased emphasis on commercial execution and partnership strategy.

QUARTER-OVER-QUARTER COMPARISON

* Management shifted from focusing primarily on pilot data generation and regulatory milestones in Q1 to emphasizing initial revenue recognition, clinical expansion, and commercial infrastructure in Q2.
* Cash use trends and investment commentary became more prominent in Q2 as clinical and commercial activities scale.
* The number of patients treated with the percutaneous electrode increased from over 90 to over 140 between Q1 and Q2, and the number of European feasibility patients for the cardiac programs also increased.
* Analyst questions this quarter placed greater emphasis on partnership development and revenue pathways, compared to the Q1 focus on early data and regulatory timelines.
* Management’s confidence in the nsPFA platform and clinical adoption remains strong, with ongoing expansion of feasibility studies and regulatory progress.

RISKS AND CONCERNS

* Management highlighted expected increases in cash use as trials and commercialization efforts expand.
* There is ongoing uncertainty regarding the timeline and structure of strategic partnerships for the catheter program.
* Reimbursement processes and site of care transitions are actively being managed to ensure commercial adoption.
* Analysts raised questions about publication of European data and how it would impact regulatory submissions, as well as the scalability of R&D spend.

FINAL TAKEAWAY

Pulse Biosciences’ Q2 2025 earnings call underscored the company’s momentum in clinical adoption and commercialization of its nsPFA technology, with over 140 patients treated in the pilot program and IDEs advancing for both cardiac clamp and catheter systems. Management projects the first revenue from the percutaneous electrode in the second half of 2025 and is scaling clinical studies and commercial infrastructure, while remaining focused on strategic partnerships and regulatory milestones. As investments and cash use rise, the company is positioning itself for expanded market presence and revenue generation in the coming quarters.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/plse/earnings/transcripts]

MORE ON PULSE BIOSCIENCES

* Pulse Biosciences, Inc. (PLSE) Q2 2025 Earnings Call Transcript [https://seekingalpha.com/article/4812877-pulse-biosciences-inc-plse-q2-2025-earnings-call-transcript]
* Seeking Alpha’s Quant Rating on Pulse Biosciences [https://seekingalpha.com/symbol/PLSE/ratings/quant-ratings]
* Historical earnings data for Pulse Biosciences [https://seekingalpha.com/symbol/PLSE/earnings]
* Financial information for Pulse Biosciences [https://seekingalpha.com/symbol/PLSE/income-statement]