Pulse Biosciences(PLSE)

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Pulse Biosciences (PLSE) FY Conference Transcript
2025-08-13 16:00
Summary of Pulse Biosciences (PLSE) FY Conference Call - August 13, 2025 Company Overview - **Company**: Pulse Biosciences - **CEO**: Paul Le Violette - **CFO**: John Skinner - **Industry**: Medical Technology, specifically focusing on pulsed electric field (PFA) therapies Core Points and Arguments - **Therapeutic Platform**: Pulse Biosciences is focused on a life-changing therapeutic platform utilizing nanosecond PFA technology to treat various diseases, including atrial fibrillation (AFib) and benign thyroid nodules [4][5][6] - **Market Potential**: The company targets multiple markets, including thyroid interventions, cardiac surgery, and electrophysiology (EP) ablation, with a total addressable market of approximately $6 billion, expected to double over time [19][20] - **PFA Technology**: The unique aspect of Pulse's PFA technology is its ability to deliver shorter pulse durations (in billionths of a second), which allows for non-thermal tissue ablation, reducing the risk of thermal damage and improving clinical outcomes [8][9][17] - **Clinical Applications**: The company has multiple FDA clearances and breakthrough designations for its technologies, indicating strong clinical validation and potential for market entry [10][11] Key Market Segments 1. **Thyroid Interventions**: - Targeting benign thyroid nodules, with 250,000 patients diagnosed annually in the U.S. and 150,000 leading to surgical removal [25][26] - Aims to convert surgical procedures into less invasive alternatives, preserving thyroid function and reducing recovery time [27][28] - Currently in a pilot program with plans for a limited launch across 10 centers [29][30] 2. **Cardiac Ablation**: - Focused on patients undergoing open-heart surgery who also have preoperative AFib, with only 25-30% currently receiving ablation therapy [32] - The technology aims to improve the efficiency and effectiveness of existing radiofrequency ablation methods [33] 3. **Electrophysiology (EP) Market**: - The largest market segment, with significant potential for NSPFA to enhance treatment speed and safety compared to first-generation PFA technologies [36][39] Financial Position - **Strong Balance Sheet**: The company reported over $100 million in cash at the end of the quarter, enabling execution of its strategic plans [14][40] Strategic Approach - **Hybrid Market Entry Strategy**: The company plans to pursue a combination of direct market entry and partnerships, focusing on capital-efficient approaches to maximize market penetration [20][21] Challenges and Considerations - **Clinical Data and Reimbursement**: The company acknowledges the importance of clinical data to drive adoption and is actively working on reimbursement strategies to facilitate market entry [43][47] - **Existing Codes**: There are existing codes for irreversible electroporation that could be leveraged for reimbursement, although thyroid is not currently an approved indication [47][48] Conclusion - **Future Outlook**: Pulse Biosciences is positioned for growth with its innovative PFA technology, targeting significant unmet needs in the medical market, and is optimistic about its potential to transform treatment paradigms in multiple therapeutic areas [39][41]
Pulse Biosciences(PLSE) - 2025 Q2 - Earnings Call Transcript
2025-08-12 21:30
Pulse Biosciences (PLSE) Q2 2025 Earnings Call August 12, 2025 04:30 PM ET Speaker0Thank you for standing by. Hello, and welcome to the Pulse Biosciences Second Quarter twenty twenty five Earnings Conference Call. Please note that this call is being recorded. I would now like to hand the call over to Trip Taylor. Sir, please go ahead.Speaker1Thank you, operator. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflect management's views as of toda ...
Pulse Biosciences(PLSE) - 2025 Q2 - Quarterly Report
2025-08-12 20:17
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34899 Pulse Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 46-5696597 (Stat ...
Pulse Biosciences(PLSE) - 2025 Q2 - Quarterly Results
2025-08-12 20:10
Exhibit 99.1 Pulse Biosciences Reports Business Updates and Second Quarter 2025 Financial Results HAYWARD, California. [Business Wire] – August 12, 2025. Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced business updates and financial results for the second quarter ended June 30, 2025. Recent Business Highlights Soft Tissue Ablation Surgical AF Ablation Endocardial Catheter AF Ablati ...
Pulse Biosciences(PLSE) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:32
Pulse Biosciences (PLSE) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Philip Taylor - Investor Relations, Gilmartin GroupPaul LaViolette - CEO & Co-Chairman of the Board of DirectorsJon Skinner - CFO Operator Good afternoon, ladies and gentlemen, and welcome to the Pulse Biosciences First Quarter twenty twenty five Financial Results Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. If at any tim ...
Pulse Biosciences(PLSE) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:30
Pulse Biosciences (PLSE) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Good afternoon, ladies and gentlemen, and welcome to the Pulse Biosciences First Quarter twenty twenty five Financial Results Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. This call is being recorded on Thursday, 05/08/2025. I would like ...
Pulse Biosciences(PLSE) - 2025 Q1 - Quarterly Report
2025-05-08 21:24
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34899 601 Brickell Key Drive, Suite 1080 Miami, FL 33131 (Address of principal executive offices) (Zip Code) ...
Pulse Biosciences(PLSE) - 2025 Q1 - Quarterly Results
2025-05-08 20:22
[Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Pulse Biosciences reports significant progress in Q1 2025, with growing clinical evidence supporting its nsPFA technology across three key device areas: soft tissue ablation, surgical AF ablation, and endocardial catheter AF ablation. The company is preparing for the commercial launch of its nsPFA Percutaneous Electrode System in H2 2025 and plans to initiate pivotal U.S. clinical trials for its cardiac systems in mid-2025 - CEO Paul LaViolette highlighted **mounting clinical evidence** for nsPFA technology and significant progress in early 2025, positioning the company for **commercial expansion and pivotal trial initiations** in mid-2025[2](index=2&type=chunk) - Key strategic advancements include: - **Expanded commercial resources** for the nsPFA Percutaneous Electrode launch in H2 2025 - **Planned U.S. clinical trial** for benign thyroid nodules in mid-2025 - **Received EU approval** to expand the patient cohort for the nsPFA Cardiac Surgery System's first-in-human AF study - **On track to commence a pivotal U.S. trial** for the nsPFA Cardiac Surgery System in mid-2025 - **Presented positive clinical data** for the nsPFA 360° catheter at the Heart Rhythm Society 2025 Meeting - **Completed treatment of 100 patients** in the European first-in-human study for the nsPFA 360° catheter - **Expects to start a U.S. IDE pivotal study** for the nsPFA 360° catheter in mid-2025[7](index=7&type=chunk) [First Quarter 2025 Financial Results](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) In Q1 2025, Pulse Biosciences reported no revenue. Total GAAP costs and expenses increased to $18.0 million, and the GAAP net loss widened to ($16.8) million from ($10.1) million year-over-year, primarily due to higher non-cash stock-based compensation and expenses related to organizational expansion for clinical trials and commercialization. The company maintained a strong cash position of $119.3 million, bolstered by $14.1 million in net proceeds from warrant exercises Q1 2025 vs Q1 2024 Key Financial Metrics | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | **GAAP Costs & Expenses** | $18.0 | $10.6 | +$7.4 | | **Non-GAAP Costs & Expenses** | $12.7 | $8.6 | +$4.1 | | **GAAP Net Loss** | ($16.8) | ($10.1) | +$6.7 | | **Non-GAAP Net Loss** | ($11.4) | ($8.1) | +$3.3 | - The increase in costs was primarily driven by **non-cash stock-based compensation** and other expenses related to **expanding the organization** to support clinical trials and commercialization[3](index=3&type=chunk)[4](index=4&type=chunk) Cash Position and Usage | Metric | As of Mar 31, 2025 (in millions) | As of Mar 31, 2024 (in millions) | As of Dec 31, 2024 (in millions) | | :--- | :--- | :--- | :--- | | **Cash and Cash Equivalents** | $119.3M | $34.9M | $118.0M | | **Cash Used in Operations (Q1)** | $13.5M | $9.8M | $9.1M (Q4 2024) | - The cash balance as of March 31, 2025, included **$14.1 million** in net proceeds from the exercise of warrants during the first quarter[5](index=5&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents the unaudited condensed consolidated financial statements as of March 31, 2025, and for the three months then ended. It includes the Balance Sheets, showing an increase in total assets and stockholders' equity, and the Statements of Operations, detailing the components of the net loss for the quarter [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, Pulse Biosciences' total assets were $133.4 million, a slight increase from $132.5 million at year-end 2024. Total liabilities decreased to $14.9 million from $17.6 million, primarily due to a reduction in accrued expenses. Consequently, total stockholders' equity increased to $118.5 million from $114.9 million Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $119,279 | $118,038 | | Total current assets | $120,909 | $119,449 | | **Total assets** | **$133,383** | **$132,460** | | Total current liabilities | $7,760 | $10,055 | | **Total liabilities** | **$14,931** | **$17,598** | | **Total stockholders' equity** | **$118,452** | **$114,862** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the first quarter of 2025, the company reported no revenue. The net loss was ($16.8) million, or ($0.25) per share, compared to a net loss of ($10.1) million, or ($0.18) per share, in Q1 2024. The increased loss was driven by higher operating expenses, with R&D costs rising to $10.3 million and G&A costs to $7.7 million, both significantly impacted by increased stock-based compensation Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenues | $— | $— | | Research and development | $10,313 | $6,741 | | General and administrative | $7,731 | $3,874 | | Loss from operations | ($18,044) | ($10,615) | | **Net loss** | **($16,795)** | **($10,137)** | | **Basic and diluted net loss per share** | **($0.25)** | **($0.18)** | Stock-Based Compensation Expense (in thousands) | Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $2,762 | $949 | | General and administrative | $2,919 | $810 | | **Total** | **$5,681** | **$1,759** | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=6&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) This section provides a detailed reconciliation of GAAP to non-GAAP financial measures for Q1 2025 and Q1 2024. The company adjusts for non-cash expenses like stock-based compensation and depreciation/amortization, as well as a legal settlement, to offer what it believes is a clearer view of its ongoing operational performance. Non-GAAP net loss for Q1 2025 was ($11.4) million, compared to the GAAP net loss of ($16.8) million - Management uses **non-GAAP measures** to supplement GAAP results, believing it aids in monitoring **ongoing financial performance** by excluding items like stock-based compensation, depreciation, amortization, and legal settlements[10](index=10&type=chunk) Reconciliation of GAAP to Non-GAAP Net Loss (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **GAAP Net loss** | **($16,795)** | **($10,137)** | | Add: Stock-based compensation expense | $5,681 | $1,759 | | Add: Depreciation and amortization | $282 | $300 | | Less: Legal settlement | ($590) | $— | | **Non-GAAP Net loss** | **($11,422)** | **($8,078)** | Reconciliation of GAAP to Non-GAAP Costs and Expenses (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **GAAP Cost and expenses** | **$18,044** | **$10,615** | | Less: Stock-based compensation expense | ($5,681) | ($1,759) | | Less: Depreciation and amortization | ($282) | ($300) | | Add: Legal settlement | $590 | $— | | **Non-GAAP Cost and expenses** | **$12,671** | **$8,556** |
Pulse Biosciences(PLSE) - 2024 Q4 - Annual Results
2025-03-28 13:09
Financial Performance - GAAP net loss for Q4 2024 was ($19.4) million, compared to ($11.9) million for Q4 2023, representing a 63.9% increase in net loss[5] - GAAP net loss for the full year 2024 was ($53.6) million, compared to ($42.2) million for 2023, indicating a 26.5% increase in net loss[10] - Non-GAAP net loss for Q4 2024 was ($10.4) million, compared to ($8.3) million for Q4 2023, reflecting a 25.3% increase in net loss[5] - The net loss for the three-month period ended December 31, 2024, was $19,385,000, compared to a net loss of $11,933,000 in the same period of 2023, reflecting a 62% increase in losses[24] - Non-GAAP net loss for the three-month period ended December 31, 2024, was $10,410,000, compared to $8,285,000 in 2023, representing a 26% increase[28] Revenue and Expenses - Total GAAP costs and expenses for Q4 2024 were $20.3 million, an increase of 61.6% from $12.5 million in Q4 2023[4] - Total GAAP costs and expenses for the full year 2024 were $56.3 million, a 29.1% increase from $43.6 million in 2023[9] - Total cost and expenses for the three-month period ended December 31, 2024, were $20,261,000, compared to $12,533,000 in 2023, reflecting a 62% increase[24] - Research and development expenses increased to $10,662,000 for the three-month period ended December 31, 2024, up from $7,799,000 in 2023, representing a 36% increase[24] - General and administrative expenses rose to $9,599,000 for the three-month period ended December 31, 2024, compared to $4,734,000 in 2023, marking a 103% increase[24] - Total stock-based compensation expense for the three-month period ended December 31, 2024, was $6,793,000, up from $3,344,000 in 2023, indicating a 103% increase[24] Cash Position - Cash and cash equivalents increased to $118.0 million as of December 31, 2024, up from $44.4 million a year earlier, reflecting a 165.5% increase[6] Clinical Developments - The company plans to initiate U.S. clinical trials for the 360° catheter and surgical clamp in mid-2025[3] - Positive preliminary results were announced from a feasibility study using nanosecond PFA technology for treating benign thyroid nodules[7] - The company treated over 80 patients in a first-in-human feasibility study for the Nanosecond PFA 360° Cardiac Catheter System[7] Share Information - Basic and diluted net loss per share for the three-month period ended December 31, 2024, was $0.31, compared to $0.21 in 2023[24] - The weighted average shares used to compute net loss per share increased to 62,056 for the three-month period ended December 31, 2024, from 57,005 in 2023[24]
Pulse Biosciences(PLSE) - 2024 Q4 - Earnings Call Transcript
2025-03-28 02:39
Financial Data and Key Metrics Changes - In Q4 2024, total GAAP costs and expenses increased by $7.7 million to $20.3 million compared to $12.5 million in the prior year period, primarily driven by an increase in non-cash stock-based compensation [55] - GAAP net loss in Q4 2024 was $19.4 million compared to $11.9 million in the prior year period, while non-GAAP net loss was $10.4 million compared to $8.3 million in the prior year period [56] - Cash and cash equivalents totaled $118 million as of December 31, 2024, compared to $44.4 million as of December 31, 2023 [57] Business Line Data and Key Metrics Changes - The company is advancing commercialization of its soft tissue ablation device, the Percutaneous Electrode, which has broad market clearance for the ablation of soft tissue, particularly for benign thyroid disease [23][27] - The surgical cardiac clamp for treating atrial fibrillation is undergoing a feasibility study in Europe, with 30 patients treated so far [36] - The 360 Catheter system for AF ablation is designed to deliver nanosecond PFA technology, targeting a $3 billion annual U.S. market for ablation catheters [40] Market Data and Key Metrics Changes - The U.S. sees approximately 250,000 patients diagnosed with benign thyroid nodules annually, with about 150,000 opting for thyroidectomy [25] - The market for atrial fibrillation treatment is significant, with over 1.9 million patients diagnosed annually in the U.S. [40] - The company expects nanosecond PFA to capture a significant share of the AF treatment market, expanding from 20% in 2024 to 40%-50% in 2025 [41] Company Strategy and Development Direction - The company aims to advance commercialization of its soft tissue ablation device and initiate pivotal studies for its cardiac catheter and surgical clamp [22] - A hybrid business model will be implemented to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] - The focus is on leveraging its differentiated technology across multiple clinical programs while maintaining operational excellence [53][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unique nanosecond PFA technology's potential to disrupt multiple clinical applications and improve patient outcomes [11][12] - The company is optimistic about its growth trajectory, with a strong balance sheet and a commitment to advancing its clinical programs [10][21] - Management highlighted the importance of robust clinical evidence to drive adoption and validate the technology's effectiveness [45] Other Important Information - The company has received seven FDA clearances and has treated 6,000 patients, indicating a mature platform for future growth [17] - The company has a portfolio of over 180 issued patents covering various systems and methods for nanosecond pulse therapies [18] - The new CFO, Jon Skinner, has joined the company and is expected to contribute significantly to its growth and operational strategies [50][53] Q&A Session Summary Question: What are the company's expectations for the commercialization of its products? - The company is focused on advancing the commercialization of its soft tissue ablation device and initiating pivotal studies for its cardiac catheter and surgical clamp [22] Question: How does the company plan to address the competitive landscape? - The company will implement a hybrid business model to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] Question: What is the outlook for the nanosecond PFA technology? - Management expressed confidence in the technology's potential to disrupt multiple clinical applications and improve patient outcomes [11][12]