ENDRA Life Sciences(NDRA) - 2020 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Operating expenses increased to $3.1 million for Q1 2020, up from $2.7 million in Q1 2019 [19] - Net loss for Q1 2020 was $3.3 million compared to a net loss of $2.7 million in Q1 2019 [20] - Cash balance as of March 31, 2020, was approximately $3.1 million, down from approximately $6.2 million as of December 31, 2019 [21] Business Line Data and Key Metrics Changes - Research and development spending decreased year-over-year by $255,000, while sales and marketing costs increased by $214,000 [19] - General and administrative costs rose by $551,000 due to employment-related costs and increased expenses associated with being a publicly traded company [19] Market Data and Key Metrics Changes - The company received CE Mark approval for the TAEUS Fatty Liver Imaging Probe (FLIP) ahead of schedule in March 2020, allowing for commercialization in Europe [11] - The company is on track to submit its 510(k) application to the FDA during the current quarter, aiming for approval in the second half of 2020 [14] Company Strategy and Development Direction - The company aims to capitalize on its CE Mark approval and first-mover advantage by launching clinical education tools and establishing evaluation sites in Europe [12] - The strategy includes building a small team of clinical market development specialists in Europe to support commercialization efforts [30] - The company is focused on two key milestones: ramping up commercialization activities in Europe and finalizing the 510(k) submission to the FDA in the U.S. [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to file the 510(k) in June and anticipates FDA approval by the end of the year [36] - The company is encouraged by the gradual return to normal operations in healthcare facilities, which aligns with their clinical partners' feedback [16] Other Important Information - The company has taken proactive actions to align its cost structure with the current economic environment, including a 33% cash salary reduction for management [22] - The company received approximately $308,000 from the Small Business Administration's Paycheck Protection Program [23] Q&A Session Summary Question: How does the company view the speed to commercialization in Europe and the U.S. against cash burn? - Management indicated a careful ramp-up of commercial spending while reducing engineering costs, ensuring a balanced approach to cash management [34] Question: Will COVID-19 impact the U.S. regulatory approval pathway? - Management believes that the submission is on track and that the FDA is remaining efficient, with confidence in filing the 510(k) in June [36] Question: What is the commercialization strategy in the U.S.? - The strategy mirrors that of Europe, focusing on building a small commercial team and leveraging clinical data from evaluation sites [40] Question: Will there be live demonstrations of the product? - Management confirmed plans for testimonials and video demonstrations once the product is in reference sites in Europe [45] Question: What are the criteria for selecting evaluation sites in the U.S.? - Evaluation sites must be centers of excellence in liver health, with a focus on early adopters and leading clinicians [52]