Acutus Medical(US:AFIB)2021-05-13 01:03Financial Data and Key Metrics Changes - The company generated sales of $3.6 million in Q1 2021, up from $1.6 million in Q1 2020 and $2.6 million in Q4 2020, driven by higher procedure volumes and increased capital equipment sales [18][24]. - Non-GAAP gross margin was negative 89% for Q1 2021, an improvement from negative 95% in Q1 2020, with excess and obsolete inventory charges impacting gross margin significantly [25][26]. - The total cash balance at the end of Q1 2021 was $106.9 million, indicating a strong liquidity position [28]. Business Line Data and Key Metrics Changes - Direct business sales increased nearly 60% to $2.4 million in Q1 2021 from $1.5 million in Q1 2020, with disposal, utilization, and service contract revenue advancing 77% [24]. - The installed base of second-generation AcQMap consoles grew to 62 by the end of Q1 2021, up from 58 at the end of Q4 2020 [18]. Market Data and Key Metrics Changes - In the U.S., utilization per system per month improved significantly, with March utilization rates about 50% above those in January, as COVID-related impacts on procedure volumes moderated [19]. - In Europe, only half of the consoles were consistently active due to COVID restrictions, but within active centers, procedure volumes and console utilization doubled compared to the prior year [20][21]. Company Strategy and Development Direction - The company focuses on three strategic priorities: technology and innovation leadership, commercial execution, and operational excellence [6][10]. - The launch of new products, including the AcQBlate Force-Sensing Ablation Catheter and AcQCross family of transseptal crossing devices, is expected to drive future performance [15][12]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in a return to normalcy in the U.S. by the second half of the year, with expectations for improved procedure volumes and capital sales [36][38]. - The company anticipates full-year revenue to be in the range of $22 million to $30 million, heavily weighted towards the back half of the year [32]. Other Important Information - The company is making progress in demand planning and cost improvement initiatives, which are expected to enhance gross margins starting in Q2 [26][30]. - The partnership with Biotronik continues to deliver strong results, with expectations for improved performance as COVID-related delays ease [22]. Q&A Session Summary Question: Guidance for the rest of the year and confidence in sales acceleration - Management expects an environment approaching normalcy in the U.S. and a return to normalcy in Europe by September, which supports confidence in sales acceleration [36][38]. Question: How to think about expenses ramping through the year - Management does not expect a meaningful expense ramp to follow revenue increases, as R&D investments are stabilizing and transitionary expenses from Q1 will not recur [42][46]. Question: Utilization within accounts and guidance assumptions - Utilization rates are expected to improve, with guidance assuming continued sequential progression in utilization across different regions [50][55]. Question: Feedback from AcQBlate users and rollout cadence - The AcQBlate system is performing well in Europe, with positive feedback from users, and the company is focused on a robust rollout without delays [71][72].