Senseonics Holdings, Inc. Reports Fourth 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 fourth
quarter and full year ended December 31, 2016.
RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
-
Submitted pre-market approval (PMA) for Eversense® to the U.S. Food
and Drug Administration (FDA) in October 2016
-
Presented full Precise II U.S. Pivotal Trial results at the 16th
Annual Diabetes Technology Meeting in Bethesda, Maryland in November
2016
-
Expanded controlled launch of Eversense with distribution partners
Rubin Medical and Roche Diabetes in Sweden, Italy and Germany
-
Expanded distribution agreements with Roche Diabetes to include
additional European countries, the Middle East (excluding Israel) and
Africa
-
Received CE Mark for the second generation Eversense Smart Transmitter
in February 2017
“We are pleased with our clinical, regulatory and commercial
achievements in 2016, 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,” said Tim
Goodnow, President and Chief Executive Officer of Senseonics. “In the
year ahead, we look forward to continuing this momentum throughout 2017
with the completion of significant regulatory milestones in the United
States and meaningful commercial sales ramp in Europe.”
FOURTH QUARTER 2016 RESULTS:
Revenue was $0.3 million for the fourth quarter of 2016, compared to no
revenue in the fourth quarter of 2015.
Fourth quarter 2016 sales and marketing expenses increased $0.5 million
year-over year, to $0.7 million, compared to $0.2 million for the fourth
quarter of 2015. The increase in sales and marketing expenses was
primarily related to investments in additional headcount in support of
the expanded commercial launch of Eversense in Europe. On a sequential
quarter comparison, fourth quarter 2016 sales and marketing expenses
were slightly less compared to the third quarter of 2016.
Fourth quarter 2016 research and development expenses increased $0.8
million year-over-year, to $5.5 million, compared to $4.7 million for
the fourth quarter of 2015. The increase in research and development
expenses 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,
fourth quarter 2016 research and development expenses decreased $1.4
million, or 25%, compared to the third quarter of 2016. The primary
driver behind this decrease is the completion of the U.S. pivotal trial
during the fourth quarter of 2016.
Fourth quarter 2016 general and administrative expenses decreased $0.3
million, year-over-year, to $3.0 million, compared to $3.3 million for
the fourth quarter of 2015. The decrease in general and administration
expenses was driven primarily by a reduction in legal expenses. On a
sequential quarter comparison, fourth quarter 2016 general and
administrative expenses increased $0.1 million, or 4%, compared to the
third quarter of 2016. The primary drivers of this increase was a $0.1
million increase in legal expense.
Net loss was $9.9 million, or $0.11 per share, in the fourth quarter of
2016, compared to $8.4 million, or $0.39 per share, in the fourth
quarter of 2015. Fourth quarter 2016 net loss per share was based on
93.4 million weighted average shares outstanding, compared to 22.0
million weighted average shares outstanding in the fourth quarter of
2015.
FULL YEAR 2016 RESULTS:
Revenue for the year ended December 31, 2016 was $0.3 million, compared
to no revenue in 2015.
Sales and marketing expenses for the year ended December 31, 2016
increased $1.9 million year-over year, to $2.7 million, compared to $0.8
million for 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.
Research and development expenses for the year ended December 31, 2016
increased $8.0 million year-over-year, to $26.3 million, compared to
$18.3 million for 2015. The increase in research and development
expenses 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.
General and administrative expenses for the year ended December 31, 2016
increased $3.2 million, year-over-year, to $13.0 million, compared to
$9.8 million for 2015. The increase in general and administration
expenses was driven primarily by an increase in personnel-related
expenses of $2.3 million, in part to support Senseonics’ operations as a
public company, and an increase of $0.9 million in facilities expenses
related to Senseonics’ expansion.
Net loss available to common stockholders was $43.9 million, or $0.49
per share, for the year ended December 31, 2016, compared to $30.3
million, or $4.32 per share, for 2015. Net loss per share for 2016 was
based on 89.2 million weighted average shares outstanding, compared to
7.0 million weighted average shares outstanding for 2015.
As of December 31, 2016, cash, cash equivalents, and marketable
securities were $20.3 million and outstanding indebtedness was $19.1
million, compared to cash and cash equivalents of $3.9 million and
outstanding indebtedness of $9.8 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, February 23, 2017, 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.comunder “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 expanded commercial launch of Eversense, future
regulatory filings, an increase in commercial sales in Europe 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
23, 2017 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.
FINANCIAL STATEMENTS TO FOLLOW:
|
|
| Senseonics Holdings, Inc. |
|
|
| Condensed Consolidated Balance Sheets |
| (in thousands, except share and per share data) |
|
| |
| |
| | December 31, |
| | 2016 | | 2015 |
| | | |
|
| Assets | | | | |
|
Current assets:
| | | | |
|
Cash and cash equivalents
| |
$
|
13,047
| | |
$
|
3,939
| |
|
Marketable securities
| | |
7,291
| | | |
—
| |
|
Accounts receivable
| | |
251
| | | |
—
| |
|
Inventory
| | |
477
| | | |
—
| |
|
Prepaid expenses and other current assets
| |
|
365
|
| |
|
1,025
|
|
|
Total current assets
| | |
21,431
| | | |
4,964
| |
| | | |
|
|
Deposits and other assets
| | |
105
| | | |
148
| |
|
Property and equipment, net
| |
|
735
|
| |
|
311
|
|
|
Total assets
| |
$
|
22,271
|
| |
$
|
5,423
|
|
| | | |
|
| Liabilities and Stockholders’ Equity (Deficit) | | | | |
|
Current liabilities:
| | | | |
|
Accounts payable
| |
$
|
3,070
| | |
$
|
1,252
| |
|
Accrued expenses and other current liabilities
| | |
4,666
| | | |
3,694
| |
|
Note payable, current portion
| |
|
3,889
|
| |
|
2,389
|
|
|
Total current liabilities
| | |
11,625
| | | |
7,335
| |
| | | |
|
|
Note payable, net of discount
| | |
15,177
| | | |
7,430
| |
|
Accrued interest
| | |
273
| | | |
327
| |
|
Other liabilities
| |
|
73
|
| |
|
28
|
|
|
Total liabilities
| |
|
27,148
|
| |
|
15,120
|
|
| | | |
|
| | | |
|
| | | |
|
|
Stockholders’ equity (deficit):
| | | | |
|
Common stock, $0.001 par value per share; 250,000,000 shares
authorized, 93,569,642 and 75,760,061 shares issued and outstanding
as of December 31, 2016 and 2015
| | |
94
| | | |
76
| |
|
Additional paid-in capital
| | |
199,751
| | | |
151,019
| |
|
Accumulated deficit
| |
|
(204,722
|
)
| |
|
(160,792
|
)
|
|
Total stockholders' deficit
| |
|
(4,877
|
)
| |
|
(9,697
|
)
|
|
Total liabilities and stockholders’ equity (deficit)
| |
$
|
22,271
|
| |
$
|
5,423
|
|
| | | | | | | |
|
|
|
| Senseonics Holdings, Inc. |
|
|
| Condensed Consolidated Statement of Operations and Comprehensive
Income (Loss) |
| (in thousands, except share and per share data) |
|
| |
| |
| |
| | Years Ended |
| | December 31, |
| | 2016 | | 2015 | | 2014 |
|
Revenue
| |
$
|
332
| | |
$
|
38
| | |
$
|
—
| |
|
Cost of sales
| |
|
660
|
| |
|
—
|
| |
|
—
|
|
|
Gross profit
| | |
(328
|
)
| | |
38
| | | |
—
| |
| | | | | |
|
|
Expenses:
| | | | | | |
|
Sales and marketing expenses
| | |
2,736
| | | |
792
| | | |
95
| |
|
Research and development expenses
| | |
26,347
| | | |
18,251
| | | |
12,881
| |
|
General and administrative expenses
| | |
13,022
| | | |
9,807
| | | |
5,726
| |
| |
| |
| |
|
|
Operating loss
| | |
(42,433
|
)
| | |
(28,812
|
)
| | |
(18,702
|
)
|
|
Other income (expense), net:
| | | | | | |
|
Interest income
| | |
80
| | | |
9
| | | |
—
| |
|
Interest expense
| | |
(1,602
|
)
| | |
(1,100
|
)
| | |
(191
|
)
|
|
Other income
| | |
25
| | | |
26
| | | |
8
| |
| |
| |
| |
|
|
Net loss
| | |
(43,930
|
)
| | |
(29,877
|
)
| | |
(18,885
|
)
|
|
Other comprehensive income (loss)
| |
|
—
|
| |
|
—
|
| |
|
—
|
|
|
Total comprehensive loss
| |
$
|
(43,930
|
)
| |
$
|
(29,877
|
)
| |
$
|
(18,885
|
)
|
| | | | | |
|
|
Deemed dividend as a result of Series E preferred stock beneficial
conversion feature
| |
|
—
|
| |
|
(407
|
)
| |
|
—
|
|
|
Net loss available to common stockholders
| |
$
|
(43,930
|
)
| |
$
|
(30,284
|
)
| |
$
|
(18,885
|
)
|
| | | | | |
|
|
Basic and diluted net loss per common share
| |
$
|
(0.49
|
)
| |
$
|
(4.32
|
)
| |
$
|
(9.89
|
)
|
|
Basic and diluted weighted-average shares outstanding
| |
|
89,243,853
|
| |
|
7,002,317
|
| |
|
1,908,587
|
|
| | | | | | | | | | | |
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20170223006656/en/
Senseonics Holdings, Inc.
INVESTOR CONTACT
R. Don Elsey
Chief
Financial Officer
301-556-1602
[email protected]
Source: Senseonics Holdings, Inc.