Release Date: March 03, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Senseonics Holdings Inc (SENS) successfully launched the Eversense 365, the world's first and only once-yearly continuous glucose monitor, in the US, receiving positive feedback from both providers and patients.
• The company has filed for CE mark approval for Eversense 365 in Europe, with plans to launch in the European Union in the second half of 2025.
• Patient base increased by 56% in 2024, surpassing the target growth of 50%, with a significant number of patients switching from competitive CGMs.
• Gross profit increased significantly in Q4 2024, driven by increased margins on the 365-day product and reduced manufacturing costs.
• Senseonics Holdings Inc (SENS) has strengthened its balance sheet by repaying convertible notes and converting preferred stock into common stock, extending its cash runway into mid-2026.

Negative Points

• Net loss for 2024 increased by $18.2 million compared to 2023, primarily due to a reduction in gains from the exchange of existing notes and changes in the fair value of derivatives.
• Total revenue for 2024 remained relatively flat compared to 2023, despite a significant increase in the patient base.
• Revenue outside the US decreased from $8.3 million in 2023 to $7.2 million in 2024.
• Research and development expenses, although decreased, still amounted to $41.1 million in 2024, reflecting ongoing high costs.
• The company faces challenges in transitioning US reimbursement from Eversense E3 to Eversense 365, particularly in the Medicare segment, which could impact revenue growth.

Q & A Highlights

• Warning! GuruFocus has detected 5 Warning Signs with SENS.

Q: What should we expect regarding inventory stocking for the OUS (Outside the United States) launch of Eversense 365? A: Tim Goodnow, President and CEO, mentioned that the inventory build-up for the OUS launch will be more gradual compared to the US. They plan to build conservatively in Europe, similar to the ongoing gradual build-up in the US.

Q: How is the prescriber base evolving, particularly with the Mercy Health partnership? A: Tim Goodnow, President and CEO, noted that there is significant excitement around the 365-day sensor, especially due to its once-a-year insertion and weekly calibration. The initial focus was on endocrinologists, but they have recently expanded to primary care, where they expect most patients to come from, particularly those with type 2 diabetes.

Q: Can you clarify the discrepancy in the number of US prescribers mentioned in the pre-announcement versus the earnings call? A: Rick Sullivan, CFO, clarified that the 1,000 prescribers mentioned were since the launch, while the 2,400 figure represents the annual number of prescribers.

Q: How much of the revenue growth is expected to come from international markets versus the US? A: Tim Goodnow, President and CEO, stated that most growth will continue to come from the US. However, they anticipate a significant increase in Europe following the launch of the 365-day product in the second half of the year.

Q: What is the status of reimbursement efforts, particularly with Medicare, for the 365-day sensor? A: Tim Goodnow, President and CEO, explained that G codes have been published, allowing reimbursement for Medicare patients. They are currently working with Medicare Administrative Contractors (MACs) on pricing, which they expect to resolve in the next quarter.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.