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:
- FDA clinical chemistry and toxicology
device panel scheduled for March 29, 2018 to review the Eversense
system
- 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
- Revenue of $2.9 million in the fourth
quarter 2017 and $6.4 million in the full year 2017
- 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.
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.com and select
the “Investor Relations” section
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
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:
Senseonics Holdings, Inc.
Consolidated Balance Sheets
(in thousands, except share and per
share data)
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 Total
current assets 44,915 21,431 Deposits and other assets 176
105 Property and equipment, net 853 735
Total assets $ 45,944 $ 22,271
Liabilities
and Stockholders’ Equity (Deficit) Current liabilities:
Accounts payable $ 7,712 $ 3,070 Accrued expenses and other current
liabilities 5,428 4,666 Notes payable, current portion
10,000 3,889 Total current liabilities 23,140
11,625 Notes payable, net of discount 14,414 15,177 Accrued
interest 1,054 273 Other liabilities 69 73
Total liabilities 38,677 27,148
Commitments and contingencies (Note 9) Stockholders’
equity (deficit): 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
Additional paid-in capital 270,953 199,751 Accumulated deficit
(263,823 ) (204,722 ) Total stockholders' equity
(deficit) 7,267 (4,877 ) Total liabilities and
stockholders’ equity (deficit) $ 45,944 $ 22,271
Senseonics Holdings, Inc.
Consolidated Statements of Operations
and Comprehensive Income (Loss)
(in thousands, except share and per
share data)
Years Ended
December 31, 2017 2016 2015 Revenue $
6,373 $ 332 $ 38 Cost of sales 9,758 660
— Gross profit (3,385 ) (328 ) 38
Expenses: Sales and marketing expenses 6,857 2,736 792 Research and
development expenses 30,735 26,347 18,251 General and
administrative expenses 15,336 13,022 9,807
Operating loss (56,313 )
(42,433 ) (28,812 ) Other income (expense), net: Interest income
135 80 9 Interest expense (3,099 ) (1,602 ) (1,100 ) Other income:
176 25 26
Net loss (59,101 ) (43,930 ) (29,877 ) Other comprehensive
income (loss) — — — Total
comprehensive loss $ (59,101 ) $ (43,930 ) $ (29,877 )
Deemed dividend as a result of Series E preferred stock beneficial
conversion feature — — (407 )
Net loss available to common stockholders $ (59,101 ) $ (43,930 ) $
(30,284 ) Basic and diluted net loss per common share $
(0.51 ) $ (0.49 ) $ (4.32 ) Basic and diluted weighted-average
shares outstanding 115,975,402 89,243,853
7,002,317
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Senseonics Holdings, Inc.INVESTOR CONTACTR. Don
ElseyChief Financial
Officer301.556.1602don.elsey@senseonics.com
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