Financial Data and Key Metrics Changes - For Q1 2023, net revenue was $4.2 million, a 13% increase from $3.7 million in Q1 2022, primarily driven by disposable sales and increases in service, rent, and other revenue [16][17] - Non-GAAP gross margin improved to negative 60% in Q1 2023 from negative 119% in Q1 2022, marking the strongest quarter since Q2 2021 [18] - Non-GAAP operating expenses were approximately $13.9 million, down 39% year-over-year, with a non-GAAP net loss of $16.8 million or $0.59 per share compared to a loss of $28.5 million or $1 per share in Q1 2022 [19][20] Business Line Data and Key Metrics Changes - Disposable revenue in Q1 2023 was $3.4 million, a 7% increase compared to the previous year, driven by growth outside the U.S. and through a distribution agreement with Medtronic [17] - The installed base of systems globally increased to 77, up from 76 in the previous quarter, with a focus on driving procedure volumes and revenue per procedure rather than just growing the installed base [16] Market Data and Key Metrics Changes - U.S. procedure volumes showed steady progress in Q1, with March commercial procedure volumes increasing over 60% month-over-month [6][7] - The company anticipates continued growth in procedure volumes and disposable product revenue throughout the year, particularly in the second half [7][20] Company Strategy and Development Direction - The company aims to drive utilization and adoption of AcQMap, focusing on complex treatment segments in the electrophysiology market [6][8] - A significant driver for growth is the product development pipeline, with plans for new product launches and clinical research to support adoption [10][11] - The company is also focused on improving financial performance, with a goal of achieving positive gross margins by Q1 2024 [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in resolving supply chain challenges that impacted Q1 results, with expectations for improved performance in Q2 and beyond [27][29] - The company is optimistic about the impact of recent clinical studies, such as RECOVER AF, on physician engagement and product adoption [39][40] Other Important Information - The company received FDA clearance for AcQMap 8.5 software, which is expected to enhance the adoption of AcQMap [11] - The partnership with Medtronic for left-heart access products is progressing well, with positive early feedback on commercial distribution [43] Q&A Session Summary Question: Update on AcQBlate timing and launch plans - Management confirmed that AcQBlate approval is expected in the second half of the year, with a focus on high utilization accounts for limited market release [24][25] Question: Comfort level around Q2 revenue expectations - Management indicated that supply chain challenges impacted Q1 results but expressed confidence in resolving these issues and achieving revenue growth in Q2 [26][27] Question: Approach to increasing installed base and procedure volumes - Management clarified that while the installed base is important, the focus is on driving procedure volume growth and increasing revenue per procedure [33][34] Question: Feedback on RECOVER AF study results - Management noted significant engagement from the physician community following the publication of RECOVER AF results, which aligns with the company's strategy to target complex patients [39][40] Question: Early feedback on Medtronic partnership - Management reported positive progress with Medtronic's commercial distribution efforts and emphasized the importance of maintaining high-quality supply to meet demand [43][44] Question: Expectations for gross margin improvements - Management expects progressive improvement in gross margins throughout the year, driven by higher production volumes and manufacturing efficiencies [46][47]
Acutus Medical(AFIB) - 2023 Q1 - Earnings Call Transcript