Asensus Surgical(US:ASXC)2022-11-11 01:02Financial Data and Key Metrics Changes - The company reported revenue of $2.6 million for Q3 2022, unchanged from Q3 2021, with system revenue of $1.2 million, lease revenue of $0.3 million, instruments and accessories revenue of $0.8 million, and services revenue of $0.3 million [12] - Total operating expenses increased to $17.2 million in Q3 2022 from $16.7 million in Q3 2021 [13] - Net loss attributable to common stockholders was $18.9 million, or $0.08 per share, compared to a net loss of $16.1 million, or $0.07 per share, in the same period last year [13] Business Line Data and Key Metrics Changes - The company installed four new Senhance systems in Q3 2022, with an additional system placement announced post-quarter, bringing the year-to-date total to five system initiations [8][21] - Procedure volumes increased by 27% year-over-year, with over 1,900 Senhance procedures completed as of September 30, 2022 [22] Market Data and Key Metrics Changes - The company has seen strong procedure volume trends in the U.S., with hospitals returning to normalized volumes and an increased number of surgeons using the Senhance system [23] - In Asia, COVID-related headwinds have resulted in a slower rebound in procedure volumes, but improvements are expected as conditions improve [24] Company Strategy and Development Direction - The company is focused on increasing awareness of the Senhance system and educating the surgical community through industry events and clinical publications [8][15] - The company aims to expand its global footprint, particularly in Japan and Germany, which are significant markets for medical devices [21][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving guidance for new system initiations, citing a robust pipeline and mature conversations with hospitals [31] - The company expects to see continued growth in procedure volumes and system installations, particularly in Europe and Asia [23][24] Other Important Information - The company received the Society of Laparoscopic and Robotic Surgeons 2022 Innovation of the Year Award for its Intelligent Surgical Unit [8] - The TRUST registry, the industry's largest robotic-assisted laparoscopic registry, has over 2,000 patients enrolled, providing valuable clinical data [16] Q&A Session Summary Question: What level of comfort do you have in hitting your target for system installations? - Management indicated a robust pipeline and mature conversations with hospitals, expressing confidence in meeting guidance numbers [31] Question: Can you quantify the transition from pilot to full commercial launch of articulating instruments? - Management stated that they are in the transition process and expect to see a ramp-up in clinical usage of the systems before the end of the year [33][34] Question: Can you provide more details on clinical data development and publication efforts? - Management highlighted the importance of real-world evidence and ongoing studies to compare clinical outcomes of Senhance versus traditional laparoscopy [35][36] Question: What are the timelines and expectations for the pediatric clearance submission? - Management expects to hear back regarding the FDA submission in the first half of 2023, following strong early clinical utilization in Europe [40]