Senseonics(SENS)2024-05-13 23:52Financial Data and Key Metrics - Q1 2024 total revenue was $5.1 million, representing 22% growth compared to the prior year period [18] - U S revenue for Q1 2024 was $3 7 million, while revenue outside the U S was $1 4 million [18] - Gross profit in Q1 2024 was $0 3 million, a decrease of $0 1 million from the prior year period, primarily due to higher fixed manufacturing costs [85] - Q1 2024 selling, general and administrative expenses were $8 1 million, an increase of $0 4 million compared to the prior year period, driven by corporate, legal, and patent expenses [22] - Operating loss for Q1 2024 was $18 2 million, compared to $19 7 million in Q1 2023, due to decreases in R&D expenses [22] - Total net loss for Q1 2024 was $18 9 million, or a $0 03 loss per share, compared to a net income of $1 3 million in Q1 2023 [98] - Cash, cash equivalents, and short-term investments totaled $99 1 million as of March 31, 2024, with debt and accrued interest at $55 9 million [98] Business Line Data and Key Metrics - The company is advancing its Eversense CGM system, with a focus on Type 2 patients on basal insulin, who historically have lower adoption rates of advanced technologies [2] - The Eversense RPM program aims to provide comprehensive diabetes management, combining CGM with remote patient monitoring to optimize care [6][19] - The company is collaborating with Mercy, a leading healthcare system, to implement a diabetes population management program using Eversense, targeting 30,000 patients across four states [42][51] - The company is working on a next-generation 365-day Eversense product, with a 510(k) submission filed with the FDA, aiming for a Q4 2024 launch [45][94] Market Data and Key Metrics - The company estimates that less than one quarter of patients eligible for CGM are currently using one, indicating significant growth potential [7] - The U S market remains a key focus, with Q1 2024 sales totaling $3 7 million, while international sales were $1 4 million [18] - The collaboration with Mercy is expected to drive growth, with a controlled launch in the St Louis metro area in July 2024, followed by a broader rollout in Q4 [8] Company Strategy and Industry Competition - The company is focusing on integrating Eversense into large health systems and accountable care organizations, leveraging its iCGM designation and RPM program to differentiate itself [14][17] - The iCGM designation allows Eversense to integrate with insulin pumps, positioning it as a strong competitor in the automated insulin delivery market [83][106] - The company is exploring partnerships with insulin pump manufacturers to further enhance its market position [20][72] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the growth potential of Eversense, particularly with the upcoming 365-day product launch and the RPM program [13][46] - The company expects Q2 2024 revenue to be consistent with Q1, with full-year guidance to be provided at the upcoming ADA conference [35][71] - Management highlighted the importance of the Mercy collaboration as a key growth catalyst, with the potential to replicate the program across other health systems [9][51] Other Important Information - The company has secured iCGM designation from the FDA, allowing Eversense to integrate with insulin pumps and other medical devices [83] - The 365-day Eversense product is expected to reduce calibration frequency and offer a full year of protection from a single sensor, enhancing its competitive position [63] - The company is working on future-generation products, including Gemini and Freedom, which aim to eliminate the need for an on-body transmitter [63] Q&A Session Summary Question: Update on Ascensia's inventory and new patient growth [88] - The company is seeing over 80% growth in new patient additions compared to the prior year, with inventory levels being managed towards normalization [99] Question: Potential impact of the Mercy collaboration and RPM program [54] - The collaboration with Mercy represents a significant opportunity, with 30,000 eligible patients identified The RPM program is designed to be scalable, with fixed costs per patient and reimbursement handled by Mercy [75] Question: Confidence in the 365-day product approval timeline [76] - The company is confident in the 510(k) submission process and is working closely with the FDA to ensure a timely approval, targeting a Q4 2024 launch [94] Question: Commercial implications of the iCGM designation [77] - The iCGM designation opens opportunities for integration with insulin pumps, though the timeline for commercial integration is still under discussion [106] Question: Details on the 30,000 eligible patients in the Mercy system [78] - The 30,000 patients are CGM-eligible but not currently using CGM, primarily Type 2 patients on insulin or with a history of hypoglycemia [104] Question: Economics of the Mercy collaboration and RPM program [92] - The RPM program follows standard healthcare reimbursement models, with fixed costs per patient and no risk-sharing arrangements [102] Question: Competitive dynamics with other CGMs in the Mercy system [107] - Mercy does not intend to switch existing CGM users but will offer Eversense to all patients, with a focus on those not currently using CGM [80]