Senseonics(US:SENS)2022-03-02 01:49Financial Data and Key Metrics Changes - In Q4 2021, total net revenue was $4 million, compared to $3.9 million in the prior year period, with U.S. revenue at $700,000 and international revenue at $3.3 million [33][15] - Gross loss in Q4 2021 was $0.5 million, a decrease of $3.1 million from a gross profit of $2.6 million in the prior year, primarily due to increased cost of goods sold [33] - Operating loss for Q4 2021 was $13.9 million, compared to a loss of $10.3 million in Q4 2020 [36] - Total net income for Q4 2021 was $84.4 million or $0.19 per share, compared to a net loss of $101.6 million or $0.41 per share in Q4 2020 [38] - Cash, cash equivalents, and investments totaled $181.8 million as of December 31, 2021 [41] Business Line Data and Key Metrics Changes - The company generated $4 million in revenue in Q4 2021, with $700,000 from the U.S. and $3.3 million from outside the U.S. [33][15] - The transition to Ascensia for commercialization has led to a decrease in selling, general, and administrative expenses to $5.8 million in Q4 2021, down from $8.2 million in the prior year [34] - Research and development expenses increased to $7.7 million in Q4 2021, up from $4.7 million in the prior year, due to expanded R&D headcount and clinical studies [35] Market Data and Key Metrics Changes - The company added over 8 million additional covered lives with positive coverage decisions from payers such as Blue Cross Blue Shield of Michigan and others [13] - The total number of covered lives for the 90-day product is approximately 210 million [65] Company Strategy and Development Direction - The company is focused on the commercial launch of the Eversense E3 system in the U.S. scheduled for April 2022, which includes product availability and broader marketing efforts [18][20] - Ascensia is establishing a dedicated CGM commercial organization to enhance patient engagement and optimize sales strategy [16] - The company plans to transition current patients to the E3 system and expand new patient and clinician adoption [17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of COVID-19 on the organization and the delay in U.S. approval, which affected rollout and progression [55] - The company expects full-year 2022 global net revenue to be in the range of $14 million to $18 million, with significant revenue expected in the second half of the year [42][46] - Management expressed confidence in the E3 product's potential to drive patient adoption and market penetration [10][49] Other Important Information - The E3 system is the longest-lasting CGM system approved in the U.S., with a wear duration of 6 months and an accuracy of 8.5% MARD [8] - The company is working on a 1-year sensor and plans to submit for IDE approval in Q2 2022 [30][31] Q&A Session Summary Question: Revenue guidance and underlying assumptions - Management discussed the impact of COVID-19 and the transition to the 180-day sensor, indicating that they expect reasonable use of the patient assistance program [53][55] Question: Recent patient volume falloff - Management noted that the biggest impact was from the withdrawal of funding for the commercial organization, with COVID-19 contributing to the decline [62][64] Question: Reimbursement progress and covered lives - Management confirmed that they are still counting about 210 million covered lives and are hopeful for coverage from major payers [65][70] Question: Pilot-at-home insertion program - Management expressed excitement about the pilot program but stated it is still in a test configuration [71] Question: Guidance modification and future ramp - Management indicated that they are not in a position to provide specific guidance for 2023 and 2024 due to the impact of COVID-19 [74] Question: Positioning against competitors - Management highlighted that Eversense remains the only implantable CGM and expects to capture a fair share of the growing market [75][76] Question: Patient assistance program impact on revenue - Management clarified that the patient assistance program is an investment that will reduce net revenue but aims to drive adoption [82]