Senseonics(US:SENS)2021-03-05 01:45Financial Data and Key Metrics Changes - In Q4 2020, total net revenue was $3.9 million, down from $9 million in Q4 2019, with U.S. revenue at $400,000 and international revenue at $3.5 million [47] - Gross profit in Q4 2020 increased by $10.8 million year-over-year to $2.6 million, primarily due to filling resupply orders with existing written-off inventory [48] - Total net loss for Q4 2020 was $101.6 million or $0.41 per share, compared to a net loss of $35.6 million or $0.18 per share in Q4 2019 [52] - As of December 31, 2020, cash and cash equivalents totaled $18.2 million, which increased to $187.3 million by January 31, 2021, following a capital raise of approximately $175 million [53] Business Line Data and Key Metrics Changes - Sales and marketing expenses decreased by $8 million year-over-year to $3 million in Q4 2020, attributed to changes from the collaboration with Ascensia [49] - Research and development expenses decreased by $5.1 million year-over-year to $4.7 million, driven by lower clinical study costs [50] Market Data and Key Metrics Changes - In the fourth quarter, revenue from outside the U.S. was $3.5 million, representing the last shipments to Roche before the expiration of the agreement [47] - The company expects global net revenues for 2021 to be between $12 million and $15 million, with a projected cash used in operations of $60 million to $65 million [54] Company Strategy and Development Direction - The company has entered a commercial collaboration agreement with Ascensia Diabetes Care, which is expected to enhance commercialization efforts and reduce sales and marketing expenses by approximately $45 million annually [16] - The focus will be on the development of next-generation diabetes products and expanding the use of on-body technology to measure other analytes beyond glucose [17] - Ascensia is now the exclusive worldwide distribution partner for all current and planned diabetes products from the company [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the partnership with Ascensia and the potential for growth in the continuous glucose monitoring (CGM) market, which is expected to see increased adoption as COVID-19 impacts lessen [59] - The company anticipates that the FDA will begin reviewing the 180-day sensor product by April 15, 2021, with hopes for approval in the third or fourth quarter of 2021 [42] Other Important Information - The company has expanded the number of U.S. covered lives to approximately 200 million patients eligible for reimbursement for Eversense [30] - Ascensia plans to introduce a prior authorization support program and a Patient Assistance Program to aid patient access to Eversense [34] Q&A Session Summary Question: Partnerships with pump manufacturers - The company has a partnership with Beta Bionics and is focusing on the ICGM designation to facilitate integration with pump partners [64] Question: Guidance confidence for $12 million to $15 million - Confidence stems from extensive collaboration with Ascensia and a dedicated installed base, with expectations of significant interest from patients [73][75] Question: Reorder rates and retention expectations - After the first sensor, reinsertion rates are about 75%, increasing to 85% after the second sensor, with expectations to return to these rates post-COVID [82] Question: Revenue cadence for 2021 - The company models approximately 40% of revenue in the first half and 60% in the second half of 2021 [86] Question: Medicare traction in Q4 - Medicare traction is still early, with a focus on training and ensuring clinical practices are comfortable with ordering and reimbursement processes [92]