Financial Data and Key Metrics Changes - In Q2 2022, total revenue was $3.7 million, an increase from $3.3 million in the prior year period [27] - U.S. revenue for Q2 was $1.2 million, while revenue outside the U.S. was $2.5 million [27] - Gross profit for Q2 2022 was $0.8 million, up from $0.4 million in the prior year [27] - Operating loss for Q2 2022 was $17 million, compared to a loss of $15.9 million in Q2 2021 [29] - Net income for Q2 2022 was $104.2 million, or $0.22 per share, compared to a net loss of $180.3 million, or $0.42 loss per share in Q2 2021 [31] Business Line Data and Key Metrics Changes - The successful commercial launch of the E3 system in the U.S. and the receipt of CE Mark for E3 in Europe were highlighted as significant achievements [9][21] - The transition to the 6-month E3 product has been completed for the current commercial base [12] - Ascensia's dedicated CGM team has been expanded to enhance sales coverage and patient awareness [13] Market Data and Key Metrics Changes - The company reported that Anthem, a major health insurance provider, is now covering the E3 system, increasing the total covered lives to approximately 250 million [18] - The transition of payer policies to cover the 6-month product is expected to continue, with most payers anticipated to complete the transition by the end of the year [16] Company Strategy and Development Direction - The company is focused on executing the E3 launch and advancing its technology pipeline, including the development of a 1-year CGM sensor [10][36] - There is a commitment to operational and manufacturing efficiency to support growth and patient adoption [10] - The company is also enhancing digital connectivity by allowing data sharing through Apple Health [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unique features of the E3 system to meet patient needs and drive adoption [6] - The company anticipates continued growth in commercial investments and sales force expansion [41] - Management acknowledged macroeconomic challenges but indicated that they have been managing these dynamics effectively [55] Other Important Information - The company has made significant progress in establishing programs to improve patient access to the E3 system [19] - The E3 system will be launched in phases across Europe, with ongoing efforts to enhance market uptake [22] Q&A Session Summary Question: On Ascensia's investments and timing for acceleration - Management confirmed that Ascensia's commercial investment is significant and expected to ramp up as products are placed in the market [41] Question: Update on the 365-day system and sensor design - Management indicated that improvements are ongoing based on clinical experience, with plans to start clinical trials by the end of the year [42] Question: Confirmation of covered lives for the 180-day sensor - Management confirmed that approximately 250 million lives are now covered for the E3 system, with ongoing transitions expected to complete by year-end [47] Question: Inventory situation at Ascensia - Management stated that the plan is to maintain about six weeks of inventory, with revenue recognized at the point of shipment [48] Question: Update on the iCGM and filing timing - Management confirmed that additional clinical data collection is underway, with plans to file for iCGM in the first half of next year [54] Question: Impact of macro conditions on sales - Management acknowledged some impact from macro conditions but noted that revenue continues to grow based on market progress [56]
Senseonics(SENS) - 2022 Q2 - Earnings Call Transcript