Senseonics Holdings Inc (NYSE:SENS) lifted its sales guidance for the fourth quarter. The company said it now expects Q4 net sales of $3.5 million, versus prior forecast of $2.5 million.
The company also received communication from the FDA explaining the reallocation of agency resources to address Emergency Use Authorization (EUA) applications for products related to the COVID-19 public health emergency is affecting marketing application reviews, including the Eversense 180-day product, which will be delayed by at least 60 days. This is consistent with what Senseonics understands other medical technology companies have reported.
Inclusion of Eversense Category III CPT codes in the Centers for Medicare & Medicaid Services (CMS) 2021 Physician Fee Schedule (PFS), establishing global payment for the device cost and procedure fees for healthcare providers across the United States.
Full-year 2021 net revenue is expected to be between $12 and $15 million, based on installed base, acceleration of Ascensia’s commercial activities and other factors
Reached agreement with Roche to facilitate transition of distribution to Ascensia, as Roche sales conclude January 31, 2021, including final purchases, transition support activities, and resolution of other matters
Highbridge second lien loan extinguished through completed conversion of their second lien debt to common stock, simplifying capital structure
SENS shares opened the abbreviated Christmas Eve session up 40 cents, 62.1%, to $1.05.
