Senseonics Holdings, Inc. Reports Fourth Quarter and Full Year 2017 Financial Results
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 fourth quarter and
full year ended December 31, 2017.
RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
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FDA clinical chemistry and toxicology device panel scheduled for March
29, 2018 to review the Eversense system
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Launched Eversense XL, the world’s longest CGM sensor life with up to
180 days continuous use, in the United Kingdom in fourth quarter 2017
and most recently into Sweden
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Revenue of $2.9 million in the fourth quarter 2017 and $6.4 million in
the full year 2017
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Completed convertible notes offering which resulted in $51.3 million
in aggregate net proceeds
“We are pleased with our fourth quarter results and accomplishments
through 2017 as well as the upcoming opportunity to present our strong
clinical data to the FDA advisory panel, which is a milestone in
building the Eversense franchise,” said Tim Goodnow, President and Chief
Executive Officer of Senseonics. “We expect that the upcoming year will
be transformational as we prepare to introduce Eversense to the U.S.
market, continue working with our distribution partners to expand our
presence in Europe and continue with the launch of Eversense XL in
Europe.”
FOURTH QUARTER 2017 RESULTS:
Revenue was $2.9 million for the fourth quarter of 2017, compared to
$0.3 million for the fourth quarter of 2016.
Fourth quarter 2017 sales and marketing expenses increased $1.6 million
year-over year, to $2.4 million. The increase in sales and marketing
expenses was primarily driven by an increase in compensation expense
associated with hiring efforts to prepare for a commercial launch of
Eversense in the United States and to support and expand the
distribution of Eversense in Europe.
Fourth quarter 2017 research and development expenses increased $2.9
million year-over-year, to $8.4 million. The increase in research and
development expenses was primarily driven by the on-going support of our
PMA application as well as additional feasibility trials.
Fourth quarter 2017 general and administrative expenses increased $0.8
million, year-over-year, to $3.8 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 $16.3 million, or $0.12 per share, in the fourth quarter of
2017, compared to $9.9 million, or $0.11 per share, in the fourth
quarter of 2016. Fourth quarter 2017 net loss per share was based on
136.8 million weighted average shares outstanding, compared to 93.4
million weighted average shares outstanding in the fourth quarter of
2016.
FULL YEAR 2017 RESULTS:
Revenue for the year ended December 31, 2017 was $6.4 million, compared
to $0.3 million in 2016.
Sales and marketing expenses for the year ended December 31, 2017
increased $4.1 million year-over year, to $6.9 million, compared to $2.7
million for 2016. The increase in sales and marketing expenses was
primarily related to investments in additional headcount in support of
the preparation for a potential U.S. commercial launch of Eversense and
support of the expanding commercial efforts of Eversense in Europe.
Research and development expenses for the year ended December 31, 2017
increased $4.4 million year-over-year, to $30.7 million, compared to
$26.3 million for 2016. The increase in research and development
expenses was primarily driven by product development expenses for future
versions of Eversense and associated clinical trial costs.
General and administrative expenses for the year ended December 31, 2017
increased $2.3 million year-over-year, to $15.3 million, compared to
$13.0 million for 2016. The increase in general and administration
expenses was driven primarily by an increase in personnel-related
expenses, increased facility expenses and increased legal and audit
expenses.
Net loss was $59.1 million, or $0.51 per share, for the year ended
December 31, 2017, compared to $43.9 million, or $0.49 per share, for
2016. Net loss per share for 2017 was based on 116.0 million weighted
average shares outstanding, compared to 89.2 million weighted average
shares outstanding for 2016.
As of December 31, 2017, cash, cash equivalents, and marketable
securities were $36.5 million and outstanding indebtedness was $24.4
million, compared to cash, cash equivalents, and marketable securities
of $20.3 million and outstanding indebtedness of $19.1 million, as of
December 31, 2016.
2018 FINANCIAL OUTLOOK
Management projects revenue for full year 2018 to be in the range of
$18.0 to $20.0 million.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 4:30 pm (Eastern Time)
today, March 13, 2018, 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:
Dial in number: (877)883-0383
Entry Number: 2850172 International dial in: (412)902-6506 | | | | | | Live Webcast Information:
Visit http://www.senseonics.comand select the “Investor
Relations” section
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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 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 regulatory
approval of Eversense in the United States, the timing of the FDA
clinical chemistry and toxicology device panel, the potential U.S.
launch of Eversense, the development of future generations of Eversense,
the expanded commercialization of Eversense and Eversense XL in Europe,
2018 financial guidance and other statements containing the words
“expect,” “intend,” “may,” “projects,” “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: uncertainties inherent
in the FDA’s approval of Eversense for marketing in the United States,
uncertainties inherent in the expanded commercial launch of Eversense
and Eversense XL in Europe 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, 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:
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Senseonics Holdings, Inc.
Consolidated Balance Sheets (in thousands, except share and per share data) |
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| | | |
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| | | |
| | | December 31, |
| | | 2017 | | | 2016 |
| Assets | | | | | | | | | | |
|
Current assets:
| | | | | | | | | | |
|
Cash and cash equivalents
| | |
$
|
16,150
| | | |
$
|
13,047
| |
|
Marketable securities
| | | |
20,300
| | | | |
7,291
| |
|
Accounts receivable
| | | |
3,382
| | | | |
251
| |
|
Inventory, net
| | | |
2,991
| | | | |
477
| |
|
Prepaid expenses and other current assets
| | |
|
2,092
|
| | |
|
365
|
|
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Total current assets
| | | |
44,915
| | | | |
21,431
| |
| | | | | | | | | |
|
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Deposits and other assets
| | | |
176
| | | | |
105
| |
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Property and equipment, net
| | |
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853
|
| | |
|
735
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|
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Total assets
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$
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45,944
|
| | |
$
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22,271
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| | | | | | | | | |
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| Liabilities and Stockholders’ Equity (Deficit) | | | | | | | | | | |
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Current liabilities:
| | | | | | | | | | |
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Accounts payable
| | |
$
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7,712
| | | |
$
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3,070
| |
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Accrued expenses and other current liabilities
| | | |
5,428
| | | | |
4,666
| |
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Notes payable, current portion
| | |
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10,000
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| | |
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3,889
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Total current liabilities
| | | |
23,140
| | | | |
11,625
| |
| | | | | | | | | |
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Notes payable, net of discount
| | | |
14,414
| | | | |
15,177
| |
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Accrued interest
| | | |
1,054
| | | | |
273
| |
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Other liabilities
| | |
|
69
|
| | |
|
73
|
|
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Total liabilities
| | |
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38,677
|
| | |
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27,148
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| | | | | | | | | |
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Commitments and contingencies (Note 9)
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| | | | | | | | | |
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Stockholders’ equity (deficit):
| | | | | | | | | | |
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Common stock, $0.001 par value per share; 250,000,000 shares
authorized, 136,882,735 and 93,569,642 shares issued and outstanding
as of December 31, 2017 and 2016
| | | |
137
| | | | |
94
| |
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Additional paid-in capital
| | | |
270,953
| | | | |
199,751
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Accumulated deficit
| | |
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(263,823
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)
| | |
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(204,722
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)
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Total stockholders' equity (deficit)
| | |
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7,267
|
| | |
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(4,877
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)
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Total liabilities and stockholders’ equity (deficit)
| | |
$
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45,944
|
| | |
$
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22,271
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| | | | | | | | | |
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Senseonics Holdings, Inc.
Consolidated Statements of Operations and Comprehensive Income
(Loss) (in thousands, except share and per share data) |
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| | | |
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| | | |
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| | | |
| | | Years Ended |
| | | December 31, |
| | | 2017 | | | 2016 | | | 2015 |
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Revenue
| | |
$
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6,373
| | | |
$
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332
| | | |
$
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38
| |
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Cost of sales
| | |
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9,758
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| | |
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660
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| | |
|
—
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Gross profit
| | | |
(3,385
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)
| | | |
(328
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)
| | | |
38
| |
| | | | | | | | | | | | | | |
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Expenses:
| | | | | | | | | | | | | | | |
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Sales and marketing expenses
| | | |
6,857
| | | | |
2,736
| | | | |
792
| |
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Research and development expenses
| | | |
30,735
| | | | |
26,347
| | | | |
18,251
| |
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General and administrative expenses
| | | |
15,336
| | | | |
13,022
| | | | |
9,807
| |
| | |
|
|
| | |
|
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| | |
|
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Operating loss
| | | |
(56,313
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)
| | | |
(42,433
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)
| | | |
(28,812
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)
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Other income (expense), net:
| | | | | | | | | | | | | | | |
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Interest income
| | | |
135
| | | | |
80
| | | | |
9
| |
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Interest expense
| | | |
(3,099
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)
| | | |
(1,602
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)
| | | |
(1,100
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)
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Other income:
| | | |
176
| | | | |
25
| | | | |
26
| |
| | |
|
|
| | |
|
|
| | |
|
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Net loss
| | | |
(59,101
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)
| | | |
(43,930
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)
| | | |
(29,877
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)
|
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Other comprehensive income (loss)
| | |
|
—
|
| | |
|
—
|
| | |
|
—
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Total comprehensive loss
| | |
$
|
(59,101
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)
| | |
$
|
(43,930
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)
| | |
$
|
(29,877
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)
|
| | | | | | | | | | | | | | |
|
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Deemed dividend as a result of Series E preferred stock beneficial
conversion feature
| | |
|
—
|
| | |
|
—
|
| | |
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(407
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)
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Net loss available to common stockholders
| | |
$
|
(59,101
|
)
| | |
$
|
(43,930
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)
| | |
$
|
(30,284
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)
|
| | | | | | | | | | | | | | |
|
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Basic and diluted net loss per common share
| | |
$
|
(0.51
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)
| | |
$
|
(0.49
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)
| | |
$
|
(4.32
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)
|
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Basic and diluted weighted-average shares outstanding
| | |
|
115,975,402
|
| | |
|
89,243,853
|
| | |
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7,002,317
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View source version on businesswire.com: http://www.businesswire.com/news/home/20180313006441/en/
Senseonics Holdings, Inc.
INVESTOR CONTACT
R. Don Elsey
Chief
Financial Officer
301.556.1602
[email protected]
Source: Senseonics Holdings, Inc.