Why Are Senseonics Shares Falling Despite FDA OK For Next-Gen Eversense CGM

The FDA has approved Senseonics Holdings Inc's SENS Eversense E3 Continuous Glucose Monitoring (CGM) System.

• The Eversense E3, including proprietary sacrificial boronic acid (SBA) technology to extend longevity to 6 months, is planned to be available to patients in the U.S. through Senseonics' commercial partner Ascensia Diabetes Care in Q2 of 2022.
• The Eversense E3 CGM System offers a fully implantable third-generation sensor with proprietary SBA technology to enhance sensor longevity.
• It demonstrated a mean absolute relative difference (MARD) of 8.5% in the PROMISE Study.
• The Company says that a 6-month sensor wear duration makes Eversense the longest-lasting CGM system available, with essentially two sensor insertion and removal procedures per year.
• A removable smart transmitter, held in place with a mild silicone-based adhesive, provides on-body vibratory alerts and data transmission to a mobile app.
• Interim Results: Senseonics expects FY22 sales of $14 million - $18 million, compared to the consensus of $30.8 million.
• For Q4 FY21 and FY21, the Company expects revenues of approximately $4 million and roughly $13.7 million, respectively. 
• In January, the Company expected FY21 sales of $12.0 million - $15.0 million.
• Cash, cash equivalents, and marketable securities at December 31, 2021, were approximately $182 million. 
• Price Action: SENS shares are down 20.30% at $2.91 during the market session on the last check Friday.