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Pulse Biosciences(PLSE) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:32
Financial Data and Key Metrics Changes - In Q1 2025, total GAAP costs and expenses increased by $7.4 million to $18 million compared to $10.6 million in the prior year period [25] - GAAP net loss in Q1 2025 was $16.8 million compared to $10.1 million in the prior year period [26] - Cash and cash equivalents totaled $119.3 million as of March 31, 2025, compared to $34.9 million as of March 31, 2024, representing an increase of $1.2 million versus year-end 2024 [26] Business Line Data and Key Metrics Changes - The company has achieved seven FDA clearances and treated over 6,000 patients, validating its proprietary mechanism of action and therapeutic potential [7] - The percutaneous electrode for soft tissue ablation has shown an average of 83% volume reduction in benign thyroid nodules at one year [13] - The three sixty catheter system for AF ablation has treated 100 patients in a feasibility study, demonstrating a 94.2% success rate for pulmonary vein isolation [22] Market Data and Key Metrics Changes - The company is expanding its direct commercial resources for the launch of its soft tissue ablation product in the U.S. [10] - Clinical data presented at various medical symposiums have increased awareness of the NSPFA technology among clinicians [11][24] Company Strategy and Development Direction - The company aims to initiate commercialization of the percutaneous electrode for soft tissue ablation and IDE pivotal studies for its cardiac devices in 2025 [8] - The focus is on building commercial infrastructure and generating revenue in the second half of 2025 [16] - The company is actively engaged with the FDA regarding the design of its IDE pivotal clinical study [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential benefits of NSPFA technology and its ability to transform care across multiple large markets [7] - The company is encouraged by the performance of its devices and expects to share preliminary results of its trials in late 2025 [18] Other Important Information - The increase in GAAP costs was primarily driven by a rise in non-cash stock-based compensation, which was $5.7 million in Q1 2025 compared to $1.8 million in the prior year [25] - Cash used in operating activities during Q1 2025 was $13.5 million, offset by $14.1 million in proceeds from the exercise of warrants [27] Q&A Session Summary - There were no questions during the Q&A session, and the call concluded with closing remarks from management [28][29]
Pulse Biosciences(PLSE) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:30
Financial Data and Key Metrics Changes - In Q1 2025, total GAAP costs and expenses increased by $7.4 million to $18 million compared to $10.6 million in the prior year period [26] - GAAP net loss in Q1 2025 was $16.8 million compared to $10.1 million in the prior year period [27] - Cash and cash equivalents totaled $119.3 million as of March 31, 2025, compared to $34.9 million as of March 31, 2024, representing an increase of $1.2 million versus year-end 2024 [27] Business Line Data and Key Metrics Changes - The company has achieved seven FDA clearances and treated over 6,000 patients, validating its proprietary mechanism of action and therapeutic potential [7] - The percutaneous electrode for soft tissue ablation has shown an average of 83% volume reduction in benign thyroid nodules at one year [13] - The three sixty catheter system for AF ablation has treated 100 patients in a feasibility study, demonstrating a 94.2% success rate for pulmonary vein isolation [22] Market Data and Key Metrics Changes - The company is expanding its direct commercial resources for the launch of its soft tissue ablation product in the U.S. [10] - Clinical data on the catheter-based treatment of atrial fibrillation were presented at major medical symposiums, indicating strong interest and potential for the technology [8][21] Company Strategy and Development Direction - The company aims to initiate commercialization of the percutaneous electrode for soft tissue ablation and IDE pivotal studies for its cardiac devices in 2025 [8] - The focus is on advancing therapies that can transform care across multiple large markets, particularly in cardiac and soft tissue applications [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential benefits of nanosecond pulse field ablation technology and its ability to disrupt existing treatment modalities [7] - The company anticipates generating revenue in the second half of 2025 as it continues to build its commercial infrastructure [16] Other Important Information - The company raised $14 million through the exercise of warrants during Q1 to maintain its cash position [10] - The FDA awarded breakthrough designation for the cardiac surgical clamp device, which is expected to enhance its regulatory process [18] Q&A Session Summary - There were no questions during the Q&A session, and the call concluded with closing remarks from management [29][30]