Senseonics Holdings (NYSE: NYSE:SENS) has maintained a Neutral rating from BTIG following the announcement that the company received FDA clearance for its 365-day Eversense continuous glucose monitoring (CGM) system.
The system is designed for adults with Type 1 and Type 2 diabetes and is comparable to its predecessor, the 180-day Eversense CGM, with an integrated continuous glucose monitoring (iCGM) designation. This designation is significant as it enables the Eversense systems to be utilized within an automated insulin delivery (AID) system.
Senseonics is currently in active discussions with pump manufacturers to potentially integrate the Eversense technology into interoperable AID systems in the future.
The company is set to begin the launch of the 365-day system in the fourth quarter of this year, in partnership with Ascensia Diabetes Care, a subsidiary of PHC Holdings (TY:6523). This timeline aligns with previous statements from the company regarding their launch plans.
In preparation for the commercial release, Senseonics has been actively marketing to both consumers and healthcare professionals to raise awareness of the new system. Additionally, efforts are underway to ensure a smooth transition of insurance coverage for the new device. However, the company anticipates that changes in inventory management will likely affect sales in the third quarter.
In other recent news, Senseonics Holdings witnessed a year-over-year revenue increase of 18% in the second quarter of 2024, amounting to $4.9 million.
The boost in revenue coincides with the FDA's approval of Senseonics' Eversense 365-day continuous glucose monitoring system (CGM) with iCGM status, a significant milestone for the company.
Analysts from Stifel maintain a Buy rating on Senseonics, citing this FDA approval and the company's steady full-year financial outlook, with global net revenue expected to be between $22 million and $24 million.
The FDA's approval enables Senseonics to engage in discussions about Automated Insulin Delivery (AID) integrations, a key factor identified by clinicians for product adoption.
The company is also planning to launch its Eversense 365-day CGM system in the fourth quarter of 2024 and is advancing its fully implantable, self-powering Gemini system.
In addition to these developments, Senseonics is preparing for a temporary decrease in revenue in the third quarter due to the transition from the 180-day to the 365-day CGM system. However, the company predicts a rise in the fourth quarter.
InvestingPro Insights
As Senseonics Holdings (NYSE:SENS) prepares for the launch of their 365-day Eversense CGM system, the financial landscape of the company presents a mix of strengths and challenges. InvestingPro data shows a market capitalization of $211.34 million, reflecting the company's current valuation in the market. Despite a significant return over the last week of 19.64%, Senseonics is grappling with a negative P/E ratio of -3.01, highlighting the company's lack of profitability in the recent period.
One of the InvestingPro Tips notes that Senseonics holds more cash than debt on its balance sheet, which is a positive sign for financial stability. However, the company is also quickly burning through cash, which could be a concern for long-term sustainability. With analysts not expecting profitability this year and a forecasted drop in net income, investors should be aware of these financial conditions when evaluating the company's future prospects.
For those looking for deeper insights, InvestingPro offers additional tips on Senseonics, detailing aspects like liquidity, valuation multiples, and profitability. There are 8 more InvestingPro Tips available for Senseonics that can provide a comprehensive view of the company's financial health and market position. To explore these further, one can visit InvestingPro for Senseonics.
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