Senseonics Holdings, Inc. Reports Third Quarter 2016 Financial Results
GERMANTOWN, Md.--(BUSINESS WIRE)--
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.
Third quarter 2016 research and development expenses increased $2.2
million year-over-year, to $6.9 million, compared to $4.7 million for
the third quarter of 2015. The increase in research and development
expense was primarily driven by product development expenses for future
versions of Eversense and clinical trial costs related to the conduct of
Senseonics’ U.S. pivotal trial. On a sequential quarter comparison,
third quarter 2016 research and development expenses decreased $0.7
million, or 9%, compared to the second quarter of 2016. The primary
driver behind this decrease is the completion of the U.S. pivotal trial.
Third quarter 2016 general and administrative expenses decreased $0.5
million, year-over-year, to $2.8 million, compared to $3.3 million for
the third quarter of 2015. The decrease in general and administration
expenses was driven primarily by a reduction in legal expenses. On a
sequential quarter comparison, third quarter 2016 general and
administrative expenses decreased $0.5 million, or 16%, compared to the
second quarter of 2016. The primary drivers of this decrease were a $0.3
million decrease in non-cash stock-based compensation expense and a $0.2
decrease in legal expense.
As of September 30, 2016, cash, cash equivalents, and marketable
securities were $25.7 million and outstanding indebtedness was $14.6
million, compared to cash and cash equivalents of $3.9 million and
outstanding indebtedness of $9.9 million, as of December 31, 2015.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 4:30 pm (Eastern Time)
today, November 3, 2016, to discuss these financial results. This
conference call can be accessed live by telephone or through Senseonics’
website.
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 glucose monitoring products
designed to help people with diabetes confidently live their lives with
ease. Senseonics’ first generation continuous glucose monitoring (CGM)
system, Eversense®, includes a small sensor, smart transmitter and
mobile application. Based on fluorescence sensing technology, the sensor
is designed to be inserted subcutaneously and communicate with the smart
transmitter to wirelessly transmit glucose levels to a mobile device.
After insertion, the sensor is designed to continually and accurately
measure glucose levels. For more information on Senseonics, please visit www.senseonics.com.
SAFE HARBOR STATEMENT
Certain statements contained in this press release, other than
statements of fact that are independently verifiable at the date hereof,
may constitute “forward-looking statements.” These forward-looking
statements reflect Senseonics’ current views about its plans,
intentions, expectations, strategies and prospects, including statements
concerning the commercial launch of Eversense, future regulatory filings
and future product enhancements. These statements are based on the
information currently available to Senseonics and on assumptions
Senseonics has made. Although Senseonics believes that its plans,
intentions, expectations, strategies and prospects as reflected in or
suggested by those forward-looking statements are reasonable, Senseonics
can give no assurance that the plans, intentions, expectations or
strategies will be attained or achieved. Furthermore, actual results may
differ materially from those described in the forward-looking statements
and will be affected by a variety of risks and factors that are beyond
Senseonics’ control. Other risks and uncertainties are more fully
described in the section entitled “Risk Factors” in Senseonics’ Annual
Report on Form 10-K filed with the Securities and Exchange Commission
(SEC) on February 19, 2016, the Quarterly Report on Form 10-Q filed with
the SEC on August 9, 2016 and its other SEC filings. Existing and
prospective investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. The
statements made in this press release speak only as of the date stated
herein, and subsequent events and developments may cause Senseonics’
expectations and beliefs to change. Unless otherwise required by
applicable securities laws, Senseonics does not intend, nor does it
undertake any obligation, to update or revise any forward-looking
statements contained in this news release to reflect subsequent
information, events, results or circumstances or otherwise.
|
| | |
| | |
| Senseonics Holdings, Inc. |
|
|
| Condensed Consolidated Balance Sheets |
| (in thousands, except share and per share data) |
| | | | | |
|
| | September 30, | | December 31, |
| | 2016 | | 2015 |
| |
(unaudited)
| | | |
| Assets | | | | | | |
|
Current assets:
| | | | | | |
|
Cash and cash equivalents
| |
$
|
16,496
| | |
$
|
3,939
| |
|
Marketable securities
| | |
9,176
| | | |
—
| |
|
Prepaid expenses and other current assets
| | |
593
| | | |
1,025
| |
|
Inventory
| |
|
329
|
| |
|
—
|
|
|
Total current assets
| | |
26,594
| | | |
4,964
| |
| | | | | |
|
|
Deposits and other assets
| | |
644
| | | |
217
| |
|
Property and equipment, net
| |
|
776
|
| |
|
311
|
|
|
Total assets
| |
$
|
28,014
|
| |
$
|
5,492
|
|
| | | | | |
|
| Liabilities and Stockholders’ Equity (Deficit) | | | | | | |
|
Current liabilities:
| | | | | | |
|
Accounts payable
| |
$
|
5,348
| | |
$
|
1,252
| |
|
Accrued expenses and other current liabilities
| | |
3,578
| | | |
3,694
| |
|
Note payable, current portion
| |
|
1,667
|
| |
|
2,389
|
|
|
Total current liabilities
| | |
10,593
| | | |
7,335
| |
| | | | | |
|
|
Note payable, net of discount
| | |
12,983
| | | |
7,499
| |
|
Accrued interest
| | |
127
| | | |
327
| |
|
Other liabilities
| |
|
86
|
| |
|
28
|
|
|
Total liabilities
| | |
23,789
| | | |
15,189
| |
| | | | | |
|
Commitments and contingencies
| | | | | | |
| | | | | |
|
|
Stockholders’ equity (deficit):
| | | | | | |
|
Preferred stock, $0.001 par value per share; 5,000,000 and 0 shares
authorized, no shares issued and outstanding as of September 30,
2016 and December 31, 2015
| | |
—
| | | |
—
| |
|
Common stock, $0.001 par value per share; 250,000,000 shares
authorized, 93,390,172 and 75,760,061 shares issued and outstanding
as of September 30, 2016 and December 31, 2015
| | |
93
| | | |
76
| |
|
Additional paid-in capital
| | |
198,889
| | | |
151,019
| |
|
Accumulated deficit
| |
|
(194,757
|
)
| |
|
(160,792
|
)
|
|
Total stockholders’ equity (deficit)
| |
|
4,225
|
| |
|
(9,697
|
)
|
|
Total liabilities and stockholders’ equity (deficit)
| |
$
|
28,014
|
| |
$
|
5,492
|
|
|
| | |
| | |
| | |
| | |
| Senseonics Holdings, Inc. |
|
|
Unaudited Condensed Consolidated Statement of Operations and
Comprehensive Income (Loss) |
| (in thousands, except share and per share data) |
| | | | | | | | | | | |
|
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2016 | | 2015 | | 2016 | | 2015 |
|
Revenue
| |
$
|
37
| | |
$
|
—
| | |
$
|
56
| | |
$
|
38
| |
|
Cost of sales
| |
|
114
|
| |
|
—
|
| |
|
148
|
| |
|
—
|
|
|
Gross profit
| | |
(77
|
)
| | |
—
| | | |
(92
|
)
| | |
38
| |
| | | | | | | | | | | |
|
|
Expenses:
| | | | | | | | | | | | |
|
Sales and marketing expenses
| | |
733
| | | |
351
| | | |
2,001
| | | |
941
| |
|
Research and development expenses
| | |
6,883
| | | |
4,682
| | | |
20,838
| | | |
13,542
| |
|
General and administrative expenses
| | |
2,819
| | | |
3,282
| | | |
10,060
| | | |
6,178
| |
| |
|
| |
|
| |
|
| |
|
|
|
Operating loss
| | |
(10,512
|
)
| | |
(8,315
|
)
| | |
(32,991
|
)
| | |
(20,623
|
)
|
|
Other income (expense), net:
| | | | | | | | | | | | |
|
Interest income
| | |
35
| | | |
2
| | | |
69
| | | |
5
| |
|
Interest expense
| | |
(502
|
)
| | |
(266
|
)
| | |
(1,045
|
)
| | |
(834
|
)
|
|
Other income (expense)
| | |
92
| | | |
(6
|
)
| | |
3
| | | |
(11
|
)
|
| |
|
| |
|
| |
|
| |
|
|
|
Net loss
| | |
(10,887
|
)
| | |
(8,585
|
)
| | |
(33,964
|
)
| | |
(21,463
|
)
|
|
Other comprehensive income (loss)
| |
|
—
|
| |
|
—
|
| |
|
—
|
| |
|
—
|
|
|
Total comprehensive loss
| |
$
|
(10,887
|
)
| |
$
|
(8,585
|
)
| |
$
|
(33,964
|
)
| |
$
|
(21,463
|
)
|
| | | | | | | | | | | |
|
|
Basic and diluted net loss per common share
| |
$
|
(0.12
|
)
| |
$
|
(4.39
|
)
| |
$
|
(0.39
|
)
| |
$
|
(11.07
|
)
|
|
Basic and diluted weighted-average shares outstanding
| |
|
93,386,139
|
| |
|
1,955,222
|
| |
|
87,838,031
|
| |
|
1,939,588
|
|
| | | | | | | | | | | | | | | |
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20161103006722/en/
Senseonics Holdings, Inc.
INVESTOR CONTACT
R. Don Elsey
Chief
Financial Officer
301-556-1602
[email protected]
Source: Senseonics Holdings, Inc.