Pulse Biosciences (PLSE) Earnings Transcript

Motley Fool Transcribing11-06

Image source: The Motley Fool. DateWednesday, November 5, 2025 at 4:30 p.m. ETCall participantsExecutive Chairman — Paul Arthur LaVioletteChief Financial Officer — Jon SkinnerCo-Chairman of the Board...

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Email [email protected]TakeawaysTotal Revenue -- $86,000 was recognized in the third quarter from initial sales of nPulse Capital and Vibrance disposables during the limited market release.GAAP Costs and Expenses -- $20.5 million, an increase of $6.8 million compared to $13.7 million in the prior year period, mainly from higher expenses for expanding NSPFA device trials, commercialization, and increased stock-based compensation.Non-GAAP Costs and Expenses -- $14.6 million, up by $4.2 million from $10.4 million in the prior year period, with stock-based compensation, depreciation, and amortization excluded from this measure.GAAP Net Loss -- $19.4 million, compared to $12.7 million in the prior year period.Non-GAAP Net Loss -- $13.5 million, versus $9.4 million a year prior.Cash and Cash Equivalents -- $95.2 million as of September 30, 2025, compared to $79 million as of September 30, 2024.Cash Used in Operating Activities -- $13 million during 2025, compared to $9 million in the prior year and $12.8 million in 2025, reflecting deliberate resource expansion and continued expense management.Initial Revenue Recognition -- Achieved as limited market commercial procedures for Vibrance began in the quarter, supported by new account launches beyond the pilot program.Pilot and Clinical Procedure Volumes -- Over 200 patients treated across the pilot program, PRECISE BGN study, and initial commercial procedures, with sequential quarterly growth in procedure volume reported.PRECISE BTN Study Progress -- More than 40% of the targeted enrollment completed, with up to 50 patients to be enrolled across four sites; enrollment expected to finish in Q1.FDA Regulatory Milestone -- IDE approval received to initiate the nPulse Cardiac Surgery System pivotal study NanoClamp AF for atrial fibrillation; first patient enrolled and treated.European Feasibility Study (Cardiac Clamp) -- Forty-four patients treated with nPulse cardiac surgical system, with ablation times as low as fifty seconds per patient; twenty-seven underwent electro-anatomical mapping at three months post-procedure.nPulse 360 Catheter Study -- 150 patients enrolled in the ongoing European feasibility study; U.S. IDE pivotal study protocol under active discussion with the FDA and targeted to commence in Q1.Commercial Strategy -- Focused effort on account utilization and commercial activity in selected geographies before expanding headcount and sales coverage.Stock-Based Compensation -- $5.6 million in 2025, accounting for 38% of the year-over-year increase in costs and expenses, compared to $3 million previously.SummaryPulse Biosciences (PLSE 3.81%) reported its first revenues, marking initial commercial adoption of its nPulse platform and Vibrance disposables in limited market release. Management emphasized continued pilot and clinical momentum, with over 200 procedures completed and pilot accounts demonstrating increased utilization. The company achieved FDA IDE approval for its NanoClamp AF pivotal study in atrial fibrillation and actively expanded its cardiac program across Europe with positive interim results shared at scientific meetings.Chief Financial Officer Jon Skinner stated, \"we expect disposables and nPulse system sales will grow along with overall procedure acceptance,\" highlighting that a significant share of current procedures fall outside revenue totals due to pilot and study participation.The PRECISE BTN study is tracking on schedule, aiming to complete enrollment in the next quarter and provide outcome data at the following update.Early international feasibility data for the cardiac clamp show rapid ablation times and emerging safety signals, while nPulse 360 pivotal IDE discussions with the FDA are advancing as planned.Management confirmed funding for the pivotal nPulse 360 study will be drawn from internal resources, with possible strategic partnerships targeted primarily for the commercialization phase rather than study execution.Industry glossaryNSPFA: Nanosecond Pulse Field Ablation; a non-thermal ablation technology delivering ultra-short, high-intensity electric fields to induce targeted cell death without heating surrounding tissue.IDE: Investigational Device Exemption; U.S. FDA regulatory status permitting the use of unapproved medical devices in clinical studies to collect safety and efficacy data.PRECISE BTN: Pulse Biosciences’ prospective, single-arm, multicenter clinical study evaluating the safety and effectiveness of nPulse Vibrance for benign thyroid nodules.Full Conference Call TranscriptPaul Arthur LaViolette: Thank you, Philip Trip Taylor. I am pleased to share the progress Pulse Biosciences has made in Q3 towards advancing our goals in each of our three market development programs. I will then turn the call over to our CFO, Jon Skinner, who will review the third quarter 2025 financial results, and we will conclude with a question and answer session joined by Bob Duggan, Co-Chair of the Board. At our core, Pulse Biosciences creates, markets, and services generated by our nPulse technology to ablate tissue in various parts of the anatomy. We are developing a portfolio of specialized devices for multiple clinical applications with a goal of creating great procedures.Nanosecond PFA is clinically differentiated from thermal ablation energies and microsecond PFA as it delivers higher, shorter bursts and lower cumulative energy levels into tissue, preventing tissue temperature rise or the spread of thermal injury. Our extensive preclinical and clinical experiences suggest nanosecond PFA should advance the speed, safety, efficacy, and workflow efficiency of prior generation energy modalities in multiple clinical specialties and has already shown the potential to be a truly disruptive technology. As a next-generation leader in pulse field ablation, Pulse Biosciences is committed to advancing transformative therapies in large and growing markets with significant unmet clinical needs. Consistently improving patient outcomes, procedural efficiency, and patient access to minimally invasive therapies.With this scientific foundation in place, we are now dedicated to executing our strategic priorities outlined at the start of the year. We are driving early targeted adoption of the mPulse Vibrance Percutaneous Electrode System for soft tissue ablation with benign thyroid nodule treatment as the first use case. This includes our pilot program, new commercialization accounts, and the initiation of the PRECISE BTN or PRECISE Benign Thyroid Nodule clinical study, all of which contribute to growing procedural utilization. We have received FDA investigational device exemption approval to study the nPulse Cardiac Surgery System for Atrial Fibrillation or AF, including the start of patient enrollment.We continue to advance our IDE submission for our nPulse 360 catheter for the treatment of atrial fibrillation. Simultaneously, we are advancing our European feasibility studies for both of our cardiac devices, with additional patients being treated with the surgical clamp and the electrophysiology catheter. Early therapy outcomes suggest market-disrupting potential, and we will continue to share new data as available in the quarters ahead. We are proud of these recent accomplishments and pleased to see the excitement grow and a bright future emerge for nanosecond PFA in the medical community. Our patient results speak volumes. Regulatory progress is essential, and we are pleased to be thoroughly engaged in that regulatory process.I will now provide more detailed updates on each of our individual market programs. Starting with our soft tissue ablation device, the nPulse Vibrance Percutaneous Electrode System. We are excited to announce our new product and technology naming. Our proprietary nanosecond PFA platform is now called nPulse Technology. Our percutaneous electrode is now the Vibrance. It was well received by physicians at the recent American Thyroid Association Annual Meeting in Scottsdale, Arizona, for the application of nspfa to these conditions. Over two hundred patients have now been treated across the pilot program, the PRECISE BGN study, and our first commercial procedures.Procedure volumes in the quarter grew on a sequential basis as positive and consistent outcomes are being reported across a growing number of providers. We are pleased to observe growing utilization with one physician completing double-digit procedures in one month, indicating scale potential for this procedure. Our commercial team's primary focus is on driving procedure count to the point of clear economic viability for our customers within a limited array of accounts and geography. We are intensely focused during this early phase, ensuring we identify proper patients, develop and train physicians and staff on consistent techniques across multiple conditions, confirm market access for commercial reimbursement, and provide clinical support to generate consistently positive outcomes.The nPulse Librance System is a first-in-class treatment, and we are very pleased with early results. Given that physicians are already caring for many patients with symptomatic benign thyroid nodules, patient flow has been positive or accelerating at all pilot sites. Patients who do not want or are not candidates for surgery, the watchful waiters, including those patients under active surveillance and those who are newly diagnosed, are all strong candidates for the Vibrance procedure. We continue to take steps to validate the potential of the Impulse Vibrant System to both convert current thyroidectomy volume and expand this overall intervention market by addressing the active surveillance pool of patients. Doctors have reported the procedure being straightforward to learn.They are able to leverage the skill set used to perform other ultrasound-guided procedures, enabling them to gain proficiency after performing just a few cases. The perceived safety benefits of the inherently non-thermal energy delivery of the nPulse system are of high importance to physicians treating benign thyroid nodules with this minimally invasive alternative to thyroidectomy. Doctor Richard Harding of the Thyroid Nodule Treatment Center recently said, quote, I have treated 15 symptomatic thyroid nodule patients. And it is the safest intervention I perform for my patients on a weekly basis. We are seeing early and significant symptomatic relief in all patients. And they are very excited and satisfied to feel like themselves again without requiring an invasive surgical procedure.Feedback across our expanding group of new users. We are encouraged to see a positive trend in insurance claims being processed and paid, which supports the clinical value of these procedures. There's a compelling economic reality to be presented for the minimally invasive organ-sparing Vibrance procedure versus the more expensive and invasive thyroidectomy that typically requires hormone replacement therapy and continual lifelong medical monitoring. We believe this economic argument will be a growing consideration for payers as we expand market access for patients and providers. We are early in our launch and focused on quality therapy development and are proud to recognize initial revenues this quarter as we initiated our limited market release during the third quarter.We have launched new accounts outside of our pilot program and completed initial commercial procedures during Q3, expecting to see procedures grow in Q4. As we progress through the rest of the year, we will maintain consistent commercial headcount in Q4 as we concentrate on expanding accounts in the existing large metropolitan geographies covered by our current commercial team. Once these initial accounts achieve the desired utilization levels, we will expand headcount and launch into new geographies. As the pilot program continues to progress, we simultaneously initiated the PRECISE BTN study with the first successful procedures of the study completed in multiple sites during the quarter.This prospective single-arm multicenter clinical study aims to generate robust clinical evidence to demonstrate the safety and effectiveness of this less invasive thyroid-preserving procedure. Benign thyroid nodule soft tissue ablation procedures will be performed on up to 50 patients at up to four sites. Study endpoints evaluated during the follow-up time points will include safety, symptoms reduction, improvements in quality of life, targeted nodule volume reduction, and cosmesis over various follow-up periods. The study is progressing according to plan, with more than forty percent enrollment to date with multiple sites up and running. We expect to complete enrollment in Q1 and will report on results at our next quarterly update.Positive data from our pilot program showcasing the safety, effectiveness, and workflow efficiency of the Impulse Vibrance Percutaneous Electric System was recently presented by Doctor Ralph Dufano at the prestigious American Thyroid Association Annual Meeting in September. And we look forward to sharing continued updates as patient follow-ups progress along, and long-term follow-up data are published in the future. Long-term follow-up evaluations of patients in our recently published Italian feasibility study are underway to further demonstrate the durability of Vibrant's thyroid treatments. Additional data and publications will play an important role in driving adoption and utilization of this novel procedure as we, as our commercial efforts scale. Let's now discuss our surgical ablation clamp.We are pleased to announce that the FDA has granted approval of our IDE pivotal study, allowing us to proceed with the initiation of the nPulse surgical ablation clamp study NanoClamp AF for the treatment of atrial fibrillation. This is the first PFA study approved by FDA for a surgical cardiac ablation device in concomitant surgical procedures. The first patient has successfully been enrolled and treated in the IVD study, marking an important step in clinically validating the nPulse cardiac surgical system. Based on active discussions and preparations, we intend to expand into additional sites by the end of the year as well as into Q1.This prospective single-arm multicenter study is designed to assess the primary effectiveness of the nPulse cardiac surgical system in treating AF during concomitant surgical surgery. I'm sorry, concomitant cardiac surgeries. Up to 136 patients will be enrolled across approximately 20 sites, including two international locations. The nPulse cardiac clamp is engineered to deliver precise, continuous, and transmural linear lesions during concomitant cardiac surgeries. Due to its non-thermal mechanism, NSPFA significantly reduces the risk of unintentional damage to surrounding tissues. This bipolar system utilizes Pulse Biosciences' proprietary nanosecond pulse field ablation, NSPFA energy, to achieve full thickness, contiguous, durable lesions with reduced ablation times compared to traditional thermal ablation methods like radiofrequency.The nPulse cardiac surgical system was granted FDA breakthrough device designation in July 2024 and is currently part of the FDA's Total Product Lifecycle Advisory, or TAP, program. The company's feasibility study continues to enroll patients in the EU and aims to evaluate the initial safety and effectiveness of the nPulse cardiac surgical system for the treatment of atrial fibrillation. To date, forty-four patients have been treated by investigators in Europe, including Doctor Bart van Putt at St. Antonius Hospital in Neuigan, Doctor Bart Mason at Maastricht Medical Center, and Doctor Antoine Dreesen at Amsterdam Medical Center.Within this initial cohort, twenty-seven patients have undergone electro-anatomical mapping approximately three months after their ablation procedures to assess the effectiveness and durability of the treatment. Initial data are incredibly promising, with individual ablation times as low as fifty seconds total per patient. Late-breaking clinical results from the feasibility study were recently presented at the renowned annual European Association for Cardiothoracic Surgery Meeting or EACS, held October 11 in Copenhagen, Denmark. As the first clinical use of an NSPFA cardiac surgical technology, the study demonstrated that the nPulse cardiac surgical clamp enables a fast, safe, and efficient workflow, highlighting its potential to significantly broaden the adoption of surgical ablation in the treatment of atrial fibrillation.We are excited to advance the IDE study while we continue to generate and publish positive patient outcomes with our feasibility study in Europe. Now, moving on to our nPulse 360 catheter for AF ablation. The nPulse 360 catheter is designed to deliver a complete circumferential lesion in a single brief energy application, eliminating the need to stop, rotate, and reposition the catheter. We believe the system offers key advantages, including lower cumulative energy delivery, potentially reduced neuromuscular stimulation, as well as the valuable ability to create deeper, more uniform lesions. The nPulse 360 catheter system's flexible design also enhances maneuverability within the left atrium, making it intuitive and user-friendly for physicians.Encouraging initial clinical outcomes from Europe confirm our belief that the benefits of nanosecond PFA delivered by the 360 catheter will significantly advance the treatment of AF for patients worldwide. Regarding current status with our IDE submission with this device, we are making positive progress. We are engaged with the FDA on our proposed IDE study protocol and expect to resolve several remaining open items over the next couple of months and will be in position to commence the study in Q1. In Europe, our ongoing feasibility study with the 360 catheter has now enrolled 150 patients by leading investigators, and follow-up on early results continues to be collected.Importantly, in what we believe will be a significant development for the AF clinical community and a positive catalyst for Pulse, we are anticipating sharing new safety and efficacy data, including one-year follow-up data from the initial cohort of patients at an upcoming scientific meeting in Q1. The EP ablation market presents a significant opportunity where a strategic partnership could accelerate Pulse's growth and quickly achieve significant market penetration. We continue to explore potential collaborations with established leaders in electrophysiology and will share updates on any partnership progress as and when appropriate. With that, I will turn the call over to Jon Skinner to speak about our third-quarter financial updates. Jon?Jon Skinner: Thank you, Paul Arthur LaViolette. Now I will highlight our GAAP and non-GAAP financial results before providing commentary on future cash use and revenue. I encourage listeners to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the third quarter, we generated our initial revenues comprised of both nPulse Capital and Vibrance disposable sales as we initiated our limited market release. Total revenue was $86,000. Total GAAP costs and expenses increased by $6.8 million to $20.5 million compared to $13.7 million in the prior year period.The increase in GAAP costs and expenses was primarily driven by an increase in expenses related to the expanding organization to support the advancement of our NSPFA device clinical trials and commercialization, along with non-cash stock-based compensation, which was $5.6 million in 2025 compared to $3 million in the prior year period. Non-cash stock-based compensation was 38% of the year-over-year increase in costs and expenses. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation as well as depreciation and amortization. Total non-GAAP costs and expenses in 2025 increased by $4.2 million to $14.6 million compared to $10.4 million in the prior year period.GAAP net loss in 2025 was $19.4 million compared to $12.7 million in the prior year period. Non-GAAP net loss in 2025 was $13.5 million compared to $9.4 million in the prior year period. As of September 30, 2025, cash and cash equivalents totaled $95.2 million compared to $79 million as of September 30, 2024, representing a decrease of $11.1 million versus 2025. Cash used in operating activities during 2025 was $13 million compared to $9 million used in the prior year period and $12.8 million in 2025. Cash used this quarter was a result of continued expense management and deliberate resource expansion. Looking ahead, we expect disposables and nPulse system sales will grow along with overall procedure acceptance.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. Our principal focus is to build a viable organization for the long term, supporting commercialization activity focused on key accounts in a few chosen geographies, as we execute our strategy to train consistent technique, confirm significant market assets as well as high volume potential, generate consistent positive outcomes, and ultimately drive account utilization prior to expanding headcount within our sales force.On the expense front, as previously stated, we expect quarterly cash use to increase as we've commenced enrollment in our cardiac surgery pivotal trial and expect to commence our EP study in the next couple of months. These essential pre-commercial investments are directly aligned with our 2025 priorities and will support development and commercial adoption of our impulse technology. This is a very exciting and focused time for Pulse Biosciences as we drive adoption of our transformational technology in soft tissue ablation and advance development of our cardiac devices for patients in need all around the world. Now joining us for the question and answer session is Bob Duggan, Co-Chairman of the Board. Operator, please open the line for questions.Operator: We will now begin the question and answer session. If you would like to ask a question, please press star 1 followed by the number one on your telephone keypad. And our first question comes from the line of Suraj Kalia with Oppenheimer and Co. Suraj, please go ahead.Suraj Kalia: Paul Arthur LaViolette, Jon Skinner, Bob Duggan, can you hear me alright?Paul Arthur LaViolette: Yes, perfect.Suraj Kalia: Gentlemen, congrats on all the progress. Paul, really three questions on the clinical trials, if I may. NanoClamp, congrats on the first enrollment. Paul, how should we think about the pre-op lesion work set done? You know, is it, like, one size fits all? Is that the approach? And, also, if I read the trial design on clinicaltrials.gov, it isn't obvious to me that left atrial appendage closure is also part of the trial. But measuring stroke is so maybe if you could give us some clarification there.Paul Arthur LaViolette: Right. Good question. So the lesion set does vary as a function of the severity of the AFib burden. And so the veins can be isolated, a full box maze can be performed. The surgeon really does have discretion in determining that lesion set. On left atrial appendage occlusion, you're right. Now we don't expect a large number of neurological events in this study. Left atrial appendage occlusion is occurring and you see that now somewhat I'll call it a dual concomitant procedure, concomitant surgery and sometimes LAA exclusion. That's obviously not part of this protocol nor would it be expected to have, essentially two therapies in one.So we are only performing the ablation procedure and we will adjudicate strokes, per norm. And that's very typical, right, within the established precedent of concomitant surgical protocols.Suraj Kalia: Fair enough. Paul, in NS 360, the pivotal trial that is expected to begin in Q1, is the thought process PULSE is going to fund this unilaterally or you still have expectations of bringing a strategic partner on?Paul Arthur LaViolette: Well, those are not mutually exclusive, first of all. So yes, our base case is that we are funding, our budget is that we are funding. We are the sponsor of the study. And the outcome is measuring the effectiveness of the 360 catheter in treating AF. So it is our study, number one. Number two, we remain committed over time to a partnership strategy, and that of course will manifest at commercialization and could become active before, including during the study. A study support partner, let's say a mapping partner, would provide mapping support in the procedure as would normally happen in any current ablation procedure.But that would not be, let's say, core support of, let's say, the strategy. The strategy for us is still we drive the study, we get approval for our device, and then our device would be supported by the mapping technology. So we would not expect funding of the study. Now, we may or may not negotiate a fee structure in a partnership. That's all speculative and to be determined. But funding specifically for the study would be expected to come off of the PULSE income statement.Suraj Kalia: Fair enough. And, Paul, finally on my side, PRECISE BTN, can you shed some additional details on what the performance criteria are? How should we compare that after, you know, the results are posted? Gentlemen, congrats on all the progress and thank you for taking my questions.Paul Arthur LaViolette: Thank you very much, Suraj. I think we have to back up and look at it as a really a novel therapy. And today, of course, a patient can have his or her thyroid removed. That becomes an effective treatment in the sense that it eliminates, let's say, the compressive symptoms for that patient. But at the same time, it also eliminates thyroid production. So measuring, let's say, the elimination of compressive symptoms is one measure for the study but cannot be the sole measure because if that were the case, it wouldn't take into account the loss of the gland. A second would be, and this is more typical of, let's say, RF ablation, pure volume reduction.What was the size of the thyroid nodule and what percent of that size was eliminated? Through a volume, rate reduction measurement. That also, in our view, is an insufficient measurement, although it's part of a base case if you will, for intervention. It's insufficient because size alone may or may not eliminate symptoms. And so, and I say that because if you ablate with RF, you can have a reduction in the raw size of the nodule but you could introduce a fibrotic ball there which itself would introduce symptoms. So what we're looking at are patient outcomes, in terms of the quality of life against an established thyroid patient scale.We're looking at volume reduction, total symptoms burden, and really trying to establish I'll call it a composite endpoint for how these patients do so relatively well. As an example, it's our observation that patients treated with NSPFA have the bulk of their lesion reduced much faster than what we observe with RF. So speed of the elimination of symptoms burden would be a new measure. And, as we said earlier, this whole notion of raw elimination of compressive symptoms in and of itself is no longer adequate because gland removal does that. But it also leaves the patient burdened with without hormone production and all of the downstream consequences of that.So that's how we're thinking about this study to really establish a landmark of new data on that composite approach to treat these patients.Operator: There's no further questions at this time. I will now turn the call back over to Paul Arthur LaViolette for closing remarks. Paul?Paul Arthur LaViolette: Thank you, operator. Well, on behalf of the entire team at Pulse Biosciences, thank you for joining. We look forward to having a very productive fourth quarter and providing you with future updates on our progress. Thank you very much.Operator: That concludes today's call. 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