Senseonics(US:SENS)2022-05-11 03:47Financial Data and Key Metrics Changes - In Q1 2022, total net revenue was $2.5 million, a decrease from $2.8 million in the prior year period [25] - U.S. revenue for Q1 was $0.8 million, while revenue outside the U.S. was $1.7 million [25] - Gross profit remained stable at $0.5 million, consistent with the prior year [25] - Operating loss for Q1 2022 was $15.2 million, compared to a loss of $11.3 million in Q1 2021 [26] - Total net income was $86.7 million or $0.19 per share, a significant increase from a net loss of $249.5 million or $0.68 per share in Q1 2021, primarily due to noncash gains related to embedded derivatives [29] Business Line Data and Key Metrics Changes - The first quarter results were driven by inventory transition plans to the new E3 product [10] - The company is focused on transitioning current users to the E3 system and expanding new patient and clinician adoption [11] Market Data and Key Metrics Changes - The global market for continuous glucose monitoring (CGM) is approximately $7 billion, with significant growth opportunities as many individuals are not yet using CGM [40] - The company anticipates a notable increase in market penetration with the E3 product, particularly among patients new to CGM [40] Company Strategy and Development Direction - The company achieved FDA approval for the Eversense E3 continuous glucose monitoring system, extending the wear duration to 6 months [7] - The strategy includes a comprehensive commercial rollout of the E3 product in the U.S. and anticipated launch in Europe in Q3 [33][21] - Significant investments are being made to enhance access and awareness initiatives for the E3 product [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early interest from patients and healthcare providers, indicating a positive commercial outlook for 2022 [39] - The company expects gross margins to approach breakeven in Q4 2022 as payer coverage transitions from the 90-day to the 6-month product [30] - The outlook for full-year 2022 global net revenue is projected to be in the range of $14 million to $18 million [30] Other Important Information - The company is actively engaged with payers to transition coverage for the E3 product, with early wins from Aetna and Humana [17] - A patient assistance program has been implemented to attract patients with commercial insurance coverage [18] Q&A Session Summary Question: What metrics are being tracked for the E3 commercial launch? - Management noted that patient and physician interest is driving metrics, with direct-to-consumer leads higher than anticipated [39] Question: What is the size of the E3 opportunity relative to the 90-day product? - Management expects significant growth, with many potential users not currently on CGM [40] Question: What is the expected timing for additional payer transitions to E3? - Management anticipates quick transitions for Medicare patients in the next couple of months, with most transitions expected in the next quarters [42] Question: How many healthcare professionals are currently implanting the 90-day sensor? - Approximately 550 medical professionals are trained for insertion, with no additional training required for the transition to the 180-day product [45] Question: What is the current inventory situation at Ascensia? - The transition from the 90-day to the E3 product is actively managed, with inventory levels being adjusted accordingly [46] Question: What is the plan for the 365-day sensor? - The IDE filing is anticipated in Q2, with the first patient insertions expected in Q4 [47] Question: How to think about cash burn over the course of the year? - Management anticipates operational expenses of about $60 million to $70 million for the year, translating to approximately $5 million per month [48]