Senseonics(US:SENS)2019-05-10 02:50Financial Data and Key Metrics Changes - The company achieved total revenue of $3.4 million in Q1 2019, an increase from $2.9 million in the prior year period, driven by U.S. sales of $800,000 and European sales of $2.6 million [8][39] - The net loss for Q1 2019 was $29.4 million, or $0.17 per share, compared to a net loss of $22.3 million, or $0.16 per share in Q1 2018 [44] - Gross margin decreased to negative $3.3 million in Q1 2019 from negative $400,000 in the prior year, primarily due to product obsolescence and expiry [42] Business Line Data and Key Metrics Changes - The U.S. revenue was $800,000, while European revenue was $2.6 million, both in line with expectations based on contractual obligations [8] - The company launched a bridge access program, which significantly increased shipments of Eversense, nearly tripling per week post-launch [12] - The number of prescriptions written each week doubled, and healthcare professionals prescribing Eversense increased by 66% [13] Market Data and Key Metrics Changes - In Europe, new users increased by 62% year-over-year, with sensor placements up by 85% [36] - The company now serves over 66 million covered lives with Eversense technology, aiming for 100 million by the end of 2019 [21] - The company received positive coverage decisions in Germany and Austria, expanding access to Eversense [34] Company Strategy and Development Direction - The company aims to expand its patient access through the bridge program and is focused on increasing payer coverage [45] - The innovation strategy includes advancing technology with a PMA supplement for a 90-day sensor and a clinical trial for a 180-day sensor [26][28] - The company is also exploring value-based coverage programs with payers to emphasize the long-term adherence and clinical outcomes of Eversense [21][87] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching the target of 100 million covered lives by the end of 2019, with ongoing discussions with major payers [56] - The company is optimistic about the early reception of the bridge program and its impact on patient access and prescriber confidence [41][48] - Management acknowledged the importance of positive patient experiences in influencing payer decisions and coverage [22] Other Important Information - The company completed its long-term post-market safety registry study in Europe, confirming high safety performance with less than 4% adverse events [30] - The company plans to present clinical data at the upcoming ADA conference, showcasing the safety and efficacy of Eversense [115] Q&A Session Summary Question: Progress on reaching 100 million covered lives - Management reported 66 million covered lives achieved, with ongoing discussions with major payers like Aetna [53][54] Question: Adoption trends in the U.S. versus Europe - Management noted significant interest from prescribers in the U.S., with a streamlined process for sensor insertions [58][60] Question: Year one launch reflections and improvements - Management expressed satisfaction with the launch, highlighting the importance of the bridge program for patient access [64][67] Question: Confidence in hitting revenue targets - Management indicated strong visibility in European revenues and positive trends in U.S. metrics [71] Question: Patient mix and new CGM users - Approximately 25% of U.S. patients are new to CGM, with the remainder coming from existing CGM users [118] Question: Medicare coverage plans - Plans for Medicare coverage discussions are set for 2020, contingent on obtaining a dosing claim [120]