Senseonics Holdings (NYSE: SENS) reported Q1 EPS of ($0.21), $0.08 worse than the analyst estimate of ($0.13).

Recent Highlights & Accomplishments:

• Completed the PROMISE study generating data to be included in the FDA Premarket Approval application for the Eversense XL system, for use up to 180 days, in the U.S. with expected filing in late summer
• Medicare Administrative Contractors (MAC) published favorable draft Local Coverage Determination (LCD) for implantable CGM devices. Four of seven MACs removed implantable CGM procedure codes from non-coverage LCDs; three more MACs expected to take the same steps
• Received positive coverage decisions for Eversense from several Blue Cross Blue Shield Plans providing access to nearly 10 million covered lives, bringing total covered lives in the U.S. to 171 million
• Commenced process to explore strategic alternatives to enhance stakeholder value
• Entered into credit facilities providing $15.0 million of immediate liquidity and access to an additional $5.0 million

“In the second half of March we began to experience significant dislocation in the market because of the isolation efforts to prevent the transmission of COVID-19. As part of the public health considerations in response to the pandemic, most endocrinology clinics transitioned to telehealth interactions with patients, greatly limiting in-person visits and significantly reducing health care providers’ ability to insert sensors for patients,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “These challenging market circumstances in combination with our financial situation led the Board to the decision to explore strategic alternatives for the company. Concurrent with this process we took steps to reorganize and reprioritize our corporate initiatives. To operate in the most efficient manner moving forward we have temporarily suspended commercial activities in the U.S. for new patients and have shifted our focus to long-term value creation through product development and market access. We remain committed to supporting our current patient base and ensuring the success of Eversense in the marketplace.”

2020 Financial Outlook

On March 26, 2020, the company withdrew its financial guidance because of the market disruption and uncertainty caused by the COVID-19 pandemic.

For earnings history and earnings-related data on Senseonics Holdings (SENS) click here.