Senseonics Holdings, Inc. Reports First Quarter 2018 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 first quarter ended
March 31, 2018.
RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
-
Favorable outcome of FDA advisory committee meeting with unanimous
support for Eversense
-
Realized revenue, through our European partners, of $2.9 million in
the first quarter 2018
-
Strengthened balance sheet with additional $53 million of gross
proceeds through completion of convertible note offering
“In the first quarter, we achieved a significant milestone with the
successful FDA panel advisory meeting and have made meaningful progress
with commercial readiness activities in the United States. We have been
simultaneously deepening our presence in the countries where Eversense
is currently available and enhancing our offering with the recent
addition of the extended life Eversense XL,” said Tim Goodnow, President
and Chief Executive Officer of Senseonics. “In the remaining time in
2018, we anticipate launching Eversense in the United States,
introducing Eversense XL across the European marketplace and initiating
a pivotal trial for labeling of up to 180 days of wear in the United
States.”
FIRST QUARTER 2018 RESULTS:
Revenue was $2.9 million for the first quarter of 2018, compared to $0.6
million for the first quarter of 2017.
First quarter 2018 sales and marketing expenses increased $2.3 million
year-over year, to $3.4 million The increase in sales and marketing
expenses was primarily driven by an increase in compensation expense
associated with hiring efforts to prepare for U.S. launch in 2018 as
well as to support and expand the distribution of Eversense in Europe.
First quarter 2018 research and development expenses increased $1.1
million year-over-year, to $8.1 million. The increase in research and
development expenses was primarily driven by the on-going support of our
PMA application as well as on-going feasibility trials.
First quarter 2018 general and administrative expenses increased $0.2
million, year-over-year, to $4.0 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 $22.3 million, or $0.16 per share, in the first quarter of
2018, compared to $13.1 million, or $0.14 per share, in the first
quarter of 2017. This increase in net loss was driven primarily by the
$4.8 million increase in the fair value of the derivative liability and
the $3.6 million increase in operating expense. First quarter 2018 net
loss per share was based on 137.1 million weighted average shares
outstanding, compared to 93.9 million weighted average shares
outstanding in the first quarter of 2017.
As of March 30, 2018, cash, cash equivalents, and marketable securities
were $65.1 million and outstanding indebtedness was $75.5 million.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 4:30 pm (Eastern Time)
today, May 10, 2018, 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 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, and potential launch, of Eversense in the United States, the
clinical development of future generations of Eversense, the expanded
commercialization of Eversense and Eversense XL in Europe, 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,
Senseonics’ Quarterly Report on Form 10-Q for the quarter ended March
31, 2018, 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. |
|
|
| Condensed Consolidated Balance Sheets |
| (in thousands, except share and per share data) |
|
| | |
| | |
| | March 31, | | December 31, |
| | 2018 | | 2017 |
| |
(unaudited)
| | | |
| Assets | | | | | | |
|
Current assets:
| | | | | | |
|
Cash and cash equivalents
| |
$
|
60,902
| | |
$
|
16,150
| |
|
Marketable securities
| | |
4,149
| | | |
20,300
| |
|
Accounts receivable, primarily from a related party
| | |
3,149
| | | |
3,382
| |
|
Inventory, net
| | |
5,248
| | | |
2,991
| |
|
Prepaid expenses and other current assets
| |
|
3,359
|
| |
|
2,092
|
|
|
Total current assets
| | |
76,807
| | | |
44,915
| |
| | | | | |
|
|
Deposits and other assets
| | |
200
| | | |
176
| |
|
Property and equipment, net
| |
|
814
|
| |
|
853
|
|
|
Total assets
| |
$
|
77,821
|
| |
$
|
45,944
|
|
| | | | | |
|
| Liabilities and Stockholders’ Equity (Deficit) | | | | | | |
|
Current liabilities:
| | | | | | |
|
Accounts payable
| |
$
|
4,922
| | |
$
|
7,712
| |
|
Accrued expenses and other current liabilities
| | |
6,560
| | | |
5,428
| |
|
Notes payable, current portion
| |
|
10,000
|
| |
|
10,000
|
|
|
Total current liabilities
| | |
21,482
| | | |
23,140
| |
| | | | | |
|
|
Notes payable, net of discount
| | |
12,022
| | | |
14,414
| |
|
Convertible senior notes, net of discount
| | |
34,015
| | | |
—
| |
|
Derivative liability
| | |
22,147
| | | |
—
| |
|
Accrued interest
| | |
1,257
| | | |
1,054
| |
|
Other liabilities
| |
|
70
|
| |
|
69
|
|
|
Total liabilities
| | |
90,993
| | | |
38,677
| |
| | | | | |
|
|
Commitments and contingencies (Note 8)
| | | | | | |
| | | | | |
|
|
Stockholders’ equity (deficit) :
| | | | | | |
|
Common stock, $0.001 par value per share; 250,000,000 shares
authorized, 137,240,202 and 136,882,735 shares issued and
outstanding as of March 31, 2018 and December 31, 2017
| | |
137
| | | |
137
| |
|
Additional paid-in capital
| | |
272,787
| | | |
270,953
| |
|
Accumulated deficit
| |
|
(286,096
|
)
| |
|
(263,823
|
)
|
|
Total stockholders' (deficit) equity
| |
|
(13,172
|
)
| |
|
7,267
|
|
|
Total liabilities and stockholders’ equity (deficit)
| |
$
|
77,821
|
| |
$
|
45,944
|
|
| | | | | | | |
|
|
|
| Senseonics Holdings, Inc. |
|
|
| Unaudited Condensed Consolidated Statement of Operations and
Comprehensive Loss |
| (in thousands, except share and per share data) |
|
| | |
| | |
| | Three Months Ended |
| | March 31, |
| | 2018 | | 2017 |
|
Revenue, primarily from a related party
| |
$
|
2,946
| | |
$
|
553
| |
|
Cost of sales
| |
|
3,308
|
| |
|
1,045
|
|
|
Gross profit
| | |
(362
|
)
| | |
(492
|
)
|
| | | | | |
|
|
Expenses:
| | | | | | |
|
Sales and marketing expenses
| | |
3,441
| | | |
1,140
| |
|
Research and development expenses
| | |
8,113
| | | |
6,998
| |
|
General and administrative expenses
| | |
4,011
| | | |
3,767
| |
|
Operating loss
| | |
(15,927
|
)
| | |
(12,397
|
)
|
|
Other income (expense), net:
| | | | | | |
|
Interest income
| | |
184
| | | |
21
| |
|
Interest expense
| | |
(1,771
|
)
| | |
(684
|
)
|
|
Other expense
| |
|
(4,759
|
)
| |
|
(13
|
)
|
|
Total other expense, net
| |
|
(6,346
|
)
| |
|
(676
|
)
|
| | | | | |
|
|
Net loss
| | |
(22,273
|
)
| | |
(13,073
|
)
|
|
Other comprehensive income (loss)
| |
|
—
|
| |
|
—
|
|
|
Total comprehensive loss
| |
$
|
(22,273
|
)
| |
$
|
(13,073
|
)
|
| | | | | |
|
|
Basic and diluted net loss per common share
| |
$
|
(0.16
|
)
| |
$
|
(0.14
|
)
|
|
Basic and diluted weighted-average shares outstanding
| |
|
137,069,008
|
| |
|
93,905,880
|
|
| | | | | | | |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20180510006223/en/
Senseonics Holdings, Inc.
INVESTOR CONTACT
R. Don Elsey
Chief
Financial Officer
301-556-1602
[email protected]
Source: Senseonics Holdings, Inc.