Pulse Biosciences(US:PLSE)2022-08-10 23:40Financial Data and Key Metrics Changes - For Q2 2022, total revenue was $265,000, with system revenue at $209,000 and cycle unit revenue at $56,000 [29] - Non-GAAP net loss for Q2 2022 was $11.9 million, an improvement from a net loss of $12.6 million in Q2 2021 and $14.2 million in Q1 2022 [35] - Cash and cash equivalents totaled $14.8 million as of June 30, 2022, down from $47.4 million a year ago but up from $12.7 million at the end of Q1 2022 [35] Business Line Data and Key Metrics Changes - The company transitioned four program participants to commercial use during the quarter, bringing total commercial conversions to 43, with 12 clinics remaining in the program [11] - Two commercial sales were completed in Q2, increasing the installed base of commercial CellFX Systems to 48 [11] Market Data and Key Metrics Changes - Revenue in North America was $214,000, representing 81% of total revenue [29] Company Strategy and Development Direction - The company is focusing on the utilization program for the CellFX System, aiming to enhance clinic integration and patient workflow [9][15] - A restructuring plan was implemented to reduce operating expenses and preserve financial resources, with a focus on increasing utilization of the CellFX Systems [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing communication with the FDA regarding regulatory submissions, which is expected to facilitate future submissions [47] - The company aims to achieve a target of 40 patients treated per month in clinics as a metric for success before expanding to new clinics [67][68] Other Important Information - The company received FDA 510(k) clearance for expanded energy settings for the CellFX System, which is expected to enhance its capabilities [20][52] - The company plans to pursue continuous improvements through additional 510(k) submissions and clearances [22] Q&A Session Summary Question: Best practices observed in the utilization program - Management is analyzing data from focused accounts to identify reproducible best practices and improve integration efficiency [41][42] Question: Clarity on future focus on capital sales - Management indicated it is too early to determine when to switch back to focusing on capital sales, emphasizing the importance of learning from current accounts [44] Question: Additional information provided to the FDA regarding regulatory submissions - Management noted productive dialogue with the FDA, providing additional clinical data as requested, which is expected to streamline future submissions [45][46] Question: Impact of expanded energy settings on dermatologists' practices - Management believes that the expanded energy settings will allow physicians to treat a broader range of lesions, enhancing the utility of the CellFX System [51][52] Question: Insights gained from clinics regarding utilization - Management highlighted the importance of understanding different clinic profiles and their specific needs to improve utilization [58] Question: How capital purchases occurred despite a focus on utilization - Management clarified that the two capital purchases were driven by clinics that expressed strong interest in the technology, rather than active sales efforts [60][62] Question: Metrics for determining when to expand commercial operations - Management set an internal goal of achieving 40 patients treated per month in clinics as a key metric before considering expansion [67][68]