GERMANTOWN, Md.--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today reported financial results for the third quarter ended September 30, 2017.
RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
- Received CE Mark for Eversense XL which extends wear of Eversense for up to 180 days
- Expanded European launch of Eversense System to six additional European countries for availability in a total of 13 countries
- Revenue of $2.1 million in the third quarter 2017
- Completed financing which brought $26 million in aggregate net proceeds to the Company
“In the third quarter, we continued to strengthen the Eversense franchise, broadening availability of the system in additional European markets, deepening our presence where Eversense has been available, and enhancing our offering with the CE Mark approval of Eversense XL,” said Tim Goodnow, President and Chief Executive Officer of Senseonics. “In the remaining time in 2017 we will be introducing Eversense XL into the first European market and working with our distribution partners for expanded launch in 2018.”
THIRD QUARTER 2017 RESULTS:
Revenue was $2.1 million for the third quarter of 2017, compared to $37,000 for the third quarter of 2016.
Third quarter 2017 sales and marketing expenses increased $1.4 million year-over year, to $2.1 million The increase in sales and marketing expenses was primarily driven by an increase in compensation expense associated with hiring efforts to support and expand the distribution of Eversense in Europe as well as preparation for U.S. launch in 2018.
Third quarter 2017 research and development expenses increased $2.9 million year-over-year, to $9.8 million. The increase in research and development expenses was primarily driven by the on-going support of our PMA application as well as the Canadian pediatric trial and additional feasibility trials.
Third quarter 2017 general and administrative expenses increased $1.1 million, year-over-year, to $3.9 million. The increase in general and administration expenses was primarily driven by an increase in compensation, legal and other administrative expense associated with supporting operational growth.
Net loss was $17.4 million, or $0.13 per share, in the third quarter of 2017, compared to $10.9 million, or $0.12 per share, in the third quarter of 2016. Third quarter 2017 net loss per share was based on 128.9 million weighted average shares outstanding, compared to 93.4 million weighted average shares outstanding in the third quarter of 2016.
As of September 30, 2017, cash, cash equivalents, and marketable securities were $52.7 million and outstanding indebtedness was $25 million, compared to cash, cash equivalents, and marketable securities of $20.3 million and outstanding indebtedness of $20 million, as of December 31, 2016.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 4:30 pm (Eastern Time) today, October 31, 2017, to discuss these financial results and recent business developments. This conference call can be accessed live by telephone or through Senseonics’ website.
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Live Teleconference Information: International dial in: (412)902-6506 |
Live Webcast Information: |
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A replay of the call can be accessed on Senseonics’ website http://www.senseonics.com under “Investor Relations.”
About Senseonics
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' CGM systems, Eversense and Eversense XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
FORWARD LOOKING STATEMENTS
Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about the potential U.S. launch of Eversense, the development of future generations of Eversense, the commercialization of Eversense XL in Europe and other statements containing the words “expect,” “intend,” “may,” “will,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the underwritten public offering on the anticipated terms or at all, uncertainties inherent in the expanded commercial launch of Eversense and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2016, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.
FINANCIAL STATEMENTS TO FOLLOW:
| Senseonics Holdings, Inc. | ||||||||
| Unaudited Condensed Consolidated Balance Sheets | ||||||||
| (in thousands, except share and per share data) | ||||||||
| September 30, | December 31, | |||||||
| 2017 | 2016 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 29,783 | $ | 13,047 | ||||
| Marketable securities | 22,917 | 7,291 | ||||||
| Accounts receivable | 2,063 | 251 | ||||||
| Inventory, net | 2,413 | 477 | ||||||
| Prepaid expenses and other current assets | 1,899 | 365 | ||||||
| Total current assets | 59,075 | 21,431 | ||||||
| Deposits and other assets | 176 | 105 | ||||||
| Property and equipment, net | 887 | 735 | ||||||
| Total assets | $ | 60,138 | $ | 22,271 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,125 | $ | 3,070 | ||||
| Accrued expenses and other current liabilities | 7,554 | 4,666 | ||||||
| Notes payable, current portion | 7,500 | 3,889 | ||||||
| Total current liabilities | 20,179 | 11,625 | ||||||
| Notes payable, net of discount | 16,801 | 15,177 | ||||||
| Accrued interest | 842 | 273 | ||||||
| Other liabilities | 66 | 73 | ||||||
| Total liabilities | 37,888 | 27,148 | ||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, $0.001 par value per share; 250,000,000 shares authorized, 136,691,128 and 93,569,642 shares issued and outstanding as of September 30, 2017 and December 31, 2016 | 136 | 94 | ||||||
| Additional paid-in capital | 269,662 | 199,751 | ||||||
| Accumulated deficit | (247,548 | ) | (204,722 | ) | ||||
| Total stockholders' equity (deficit) | 22,250 | (4,877 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 60,138 | $ | 22,271 | ||||
| Senseonics Holdings, Inc. | ||||||||||||||||
| Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue | $ | 2,097 | $ | 37 | $ | 3,464 | $ | 56 | ||||||||
| Cost of sales | 2,957 | 114 | 5,716 | 148 | ||||||||||||
| Gross profit | (860 | ) | (77 | ) | (2,252 | ) | (92 | ) | ||||||||
| Expenses: | ||||||||||||||||
| Sales and marketing expenses | 2,089 | 733 | 4,478 | 2,001 | ||||||||||||
| Research and development expenses | 9,765 | 6,883 | 22,368 | 20,838 | ||||||||||||
| General and administrative expenses | 3,891 | 2,819 | 11,545 | 10,060 | ||||||||||||
| Operating loss | (16,605 | ) | (10,512 | ) | (40,643 | ) | (32,991 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 129 | 35 | 187 | 69 | ||||||||||||
| Interest expense | (915 | ) | (502 | ) | (2,365 | ) | (1,045 | ) | ||||||||
| Other income (expense): | 12 | 92 | (5 | ) | 3 | |||||||||||
| Net loss | (17,379 | ) | (10,887 | ) | (42,826 | ) | (33,964 | ) | ||||||||
| Total comprehensive loss | $ | (17,379 | ) | $ | (10,887 | ) | $ | (42,826 | ) | $ | (33,964 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.13 | ) | $ | (0.12 | ) | $ | (0.39 | ) | $ | (0.39 | ) | ||||
| Basic and diluted weighted-average shares outstanding | 128,898,682 | 93,386,139 | 108,959,779 | 87,838,031 | ||||||||||||
