Senseonics(US:SENS)2023-08-10 22:29Financial Data and Key Metrics Changes - In Q2 2023, total revenue was $4.1 million, an 11% increase compared to the prior year period, with U.S. revenue at $1.8 million and international revenue at $2.3 million [7][26] - Operating loss for Q2 2023 was $19.9 million, compared to $17 million in Q2 2022, primarily due to increased R&D investments [29] - Net loss for Q2 2023 was $20.4 million or $0.04 loss per share, compared to a net income of $104.2 million or $0.22 gain per share in Q2 2022 [29] - Gross profit in Q2 2023 was $0.4 million, a decrease from $0.8 million in the prior year period, driven by an increase in revenue share percentage due to Ascensia [37] Business Line Data and Key Metrics Changes - Over 12% of total insertions in Q2 2023 were completed by MPG, more than double the prior quarter, with Eversense insertions in over 30 cities [9] - The dedicated salesforce is planned to increase to 50 professionals, currently at about 45 reps [8] Market Data and Key Metrics Changes - UnitedHealthcare began covering Eversense as of July 1, adding 45 million lives to the coverage population [5][18] - The company is seeing attractive growth in Italy, its second-largest European market, while addressing reimbursement issues in Germany [10] Company Strategy and Development Direction - The company is focused on increasing awareness and access to Eversense through enhanced branding and consumer-facing materials [3] - A pivotal trial for a 365-day sensor is nearing completion, with expectations for positive results to transform diabetes management [24] - The company aims to extend the wear time of Eversense to one year and has submitted for iCGM designation to integrate with insulin delivery devices [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in a significant ramp in U.S. growth in the second half of the year, driven by additional sales reps and new coverage from UnitedHealthcare [50] - The company reiterated its full-year 2023 global net revenue guidance to be in the range of $20 million to $24 million, reflecting expected patient growth [42] Other Important Information - Research and development expenses in Q2 2023 were $12.8 million, an increase of $3.5 million compared to the prior year, due to investments in product pipeline and clinical trials [28] - The company entered into exchange agreements to reduce outstanding indebtedness to approximately $20.4 million, providing additional financial flexibility [30][31] Q&A Session Summary Question: Was there any outsized Ascensia destocking domestically? - Management indicated that Ascensia was optimizing their stocking levels as anticipated, and a significant ramp is expected in the second half of the year [49] Question: What gives confidence in the full-year guidance reiteration? - Confidence is based on expected U.S. growth driven by additional sales reps and new coverage from UnitedHealthcare [50] Question: What percent of new users are taking advantage of the patient assistance program? - Less than 50% were utilizing the patient assistance program in the first half of the year, with expectations for a decrease following UnitedHealthcare coverage [57] Question: What is the current mix of inserters between endocrinology and non-endocrinology? - The majority of inserters are still endocrinology, but the non-endocrinology segment is growing rapidly [60] Question: Will the 365-day data be press released? - Management indicated it is not advisable to press release data before it is peer-reviewed and submitted to the FDA [61] Question: What is the impact of GLP-1s on the business? - No impact has been observed to date, and management does not foresee any significant effect on market opportunities in the near term [63]