Senseonics Holdings, Inc. (NYSE-MKT: SENS), a medical technology company focused on the development and commercialization of Eversense®, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today reported financial results for the third quarter and nine months ended September 30, 2016. RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
Completed Eversense® U.S. pivotal trial and released top-line results
Eversense® PMA submitted to FDA in October
German launch initiated late September
"We continued to make progress on both the clinical and regulatory front as well as in our commercial roll-out in Europe," said Tim Goodnow, President and Chief Executive Officer of Senseonics. "The submission of our PMA to the FDA represented a major milestone for the company as we move closer to bringing the Eversense system to people with diabetes in the United States." Dr. Mark Christiansen, lead clinician in the PRECISE II trial, will present "PRECISE II Pivotal Trail: 90-Day Subcutaneously Implanted Glucose Sensor" at 8:25 a.m. EST on November 10, 2016. Senseonics intends to contemporaneously file a Current Report on Form 8-K with the U.S. Securities and Exchange Commission on November 10, 2016 containing a copy of Dr. Christensen's presentation. An archived copy of this presentation will be made available on Senseonics' website. THIRD QUARTER 2016 RESULTS: Net loss was $10.9 million, or $0.12 per share, in the third quarter of 2016, compared to $8.6 million, or $4.39 per share, in the third quarter of 2015. Third quarter 2016 net loss per share was based on 93.4 million weighted-average shares outstanding, compared to 1.9 million weighted-average shares outstanding in the third quarter of 2015. Third quarter 2016 sales and marketing expenses increased $0.3 million year-over year to $0.7 million, compared to $0.4 million for the third quarter of 2015. The increase in sales and marketing expenses was primarily related to investments in additional headcount in support of the commercial launch of Eversense in Europe. On a sequential quarter comparison, third quarter 2016 sales and marketing expense increased $0.1 million compared to the second quarter of 2016.