Senseonics Holdings, Inc. Reports First Quarter 2017 Financial Results
GERMANTOWN, Md.--(BUSINESS WIRE)--
Senseonics Holdings, Inc. (NYSE-MKT: 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, 2017.
RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
-
Broadening commercial launch in Germany and Sweden with distributors
planning to be in eight European countries by mid-year 2017.
-
Received CE Mark for the second generation Eversense® Smart
Transmitter in February 2017. This redesigned transmitter is slimmer,
lighter and water-resistant for added convenience and comfort in use.
-
Initial preparations underway for U.S. commercial infrastructure
through addition of industry veteran Mike Gill as Vice President of
Sales. Mr. Gill previously built and managed commercial efforts for
Medtronic Diabetes Americas Region to sales of over $1 billion in
insulin pump and CGM sensors.
-
Anticipate Eversense XL CGM System approval in Europe in the coming
months, which would extend the sensor life label for up to 180-day
use, as the CE Mark amendment for this version is under review.
“We are excited about our strong start in 2017, building and expanding
our commercial presence in Europe. With CE mark approval for our second
generation smart transmitter, we are also moving forward on clinical and
regulatory milestones,” said Tim Goodnow, President and Chief Executive
Officer of Senseonics. “We continue to work closely with the FDA towards
the approval of our PMA for Eversense, and we are pleased to begin
building the infrastructure for initial commercial launch preparation in
the United States. We look to accelerate this positive momentum
throughout the rest of the year.”
FIRST QUARTER 2017 RESULTS:
Revenue was $0.6 million for the first quarter of 2017. There was no
revenue in the first quarter of 2016.
First quarter 2017 sales and marketing expenses increased $0.5 million
year-over year, to $1.1 million, compared to $0.6 million for the first
quarter of 2016. The increase in sales and marketing expenses was
primarily related to investments in additional headcount and costs to
support the expanded commercial launch of Eversense in Europe. On a
sequential quarter comparison, first quarter 2017 sales and marketing
expenses increased $0.4 million compared to the fourth quarter of 2016.
First quarter 2017 research and development expenses increased $0.6
million year-over-year, to $7.0 million, compared to $6.4 million for
the first quarter of 2016. The increase in research and development
expenses was primarily driven by product development expenses for future
versions of Eversense. On a sequential quarter comparison, first quarter
2017 research and development expenses increased $1.5 million, or 27%,
compared to the fourth quarter of 2016.
First quarter 2017 general and administrative expenses decreased $0.1
million, year-over-year, to $3.8 million, compared to $3.9 million for
the first quarter of 2016. The decrease in general and administration
expenses was driven primarily by a decrease in stock based compensation
costs offset by increased costs in other expenses to support
administration. On a sequential quarter comparison, first quarter 2017
general and administrative expenses increased $0.8 million, or 27%,
compared to the fourth quarter of 2016.
Net loss was $13.1 million, or $0.14 per share, in the first quarter of
2017, compared to $11.2 million, or $0.15 per share, in the first
quarter of 2016. First quarter 2017 net loss per share was based on 93.9
million weighted average shares outstanding, compared to 77.3 million
weighted average shares outstanding in the first quarter of 2016.
As of March 31, 2017, cash, cash equivalents, and marketable securities
were $13.8 million and outstanding indebtedness was $25 million,
compared to cash and cash equivalents of $37.4 million and outstanding
indebtedness of $10 million, as of March 31, 2016.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 4:30 pm (Eastern Time)
today, May 4, 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, marketing
approval of Eversense in the United States and the Eversense XL CGM
System 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. |
|
|
| Unaudited Condensed Consolidated Balance Sheets |
| (in thousands, except share and per share data) |
| | | | | |
|
| | March 31, | | December 31, |
| | 2017 | | 2016 |
| | | | |
|
| Assets | | | | | | |
|
Current assets:
| | | | | | |
|
Cash and cash equivalents
| |
$
|
11,771
| | |
$
|
13,047
| |
|
Marketable securities
| | |
2,000
| | | |
7,291
| |
|
Accounts receivable
| | |
406
| | | |
251
| |
|
Inventory
| | |
507
| | | |
477
| |
|
Prepaid expenses and other current assets
| |
|
737
|
| |
|
365
|
|
|
Total current assets
| | |
15,421
| | | |
21,431
| |
| | | | | |
|
|
Deposits and other assets
| | |
105
| | | |
105
| |
|
Property and equipment, net
| |
|
701
|
| |
|
735
|
|
|
Total assets
| |
$
|
16,227
|
| |
$
|
22,271
|
|
| | | | | |
|
| Liabilities and Stockholders’ Equity (Deficit) | | | | | | |
|
Current liabilities:
| | | | | | |
|
Accounts payable
| |
$
|
3,161
| | |
$
|
3,070
| |
|
Accrued expenses and other current liabilities
| | |
5,322
| | | |
4,666
| |
|
Note payable, current portion
| |
|
2,500
|
| |
|
3,889
|
|
|
Total current liabilities
| | |
10,983
| | | |
11,625
| |
| | | | | |
|
|
Note payable, net of discount
| | |
21,577
| | | |
15,177
| |
|
Accrued interest
| | |
450
| | | |
273
| |
|
Other liabilities
| |
|
59
|
| |
|
73
|
|
|
Total liabilities
| |
|
33,069
|
| |
|
27,148
|
|
| | | | | |
|
|
Commitments and contingencies
| | | | | | |
| | | | | |
|
|
Stockholders’ equity (deficit):
| | | | | | |
|
Common stock, $0.001 par value per share; 250,000,000 shares
authorized, 94,098,515 and 93,569,642 shares issued and outstanding
as of March 31, 2017 and December 31, 2016
| | |
94
| | | |
94
| |
|
Additional paid-in capital
| | |
200,859
| | | |
199,751
| |
|
Accumulated deficit
| |
|
(217,795
|
)
| |
|
(204,722
|
)
|
|
Total stockholders' deficit
| |
|
(16,842
|
)
| |
|
(4,877
|
)
|
|
Total liabilities and stockholders’ equity (deficit)
| |
$
|
16,227
|
| |
$
|
22,271
|
|
|
| | |
| | |
| Senseonics Holdings, Inc. |
|
|
| Unaudited Condensed Consolidated Statement of Operations and
Comprehensive Income (Loss) |
| (in thousands, except share and per share data) |
| | | | | |
|
| | Three Months Ended |
| | March 31, |
| | 2017 | | 2016 |
|
Revenue
| |
$
|
553
| | |
$
|
—
| |
|
Cost of sales
| |
|
1,045
|
| |
|
—
|
|
|
Gross profit
| | |
(492
|
)
| | |
—
| |
| | | | | |
|
|
Expenses:
| | | | | | |
|
Sales and marketing expenses
| | |
1,140
| | | |
633
| |
|
Research and development expenses
| | |
6,998
| | | |
6,416
| |
|
General and administrative expenses
| | |
3,767
| | | |
3,879
| |
| |
|
| |
|
|
|
Operating loss
| | |
(12,397
|
)
| | |
(10,928
|
)
|
|
Other income (expense), net:
| | | | | | |
|
Interest income
| | |
21
| | | |
2
| |
|
Interest expense
| | |
(684
|
)
| | |
(276
|
)
|
|
Other expense
| | |
(13
|
)
| | |
(14
|
)
|
| |
|
| |
|
|
|
Net loss
| | |
(13,073
|
)
| | |
(11,216
|
)
|
|
Other comprehensive income (loss)
| |
|
—
|
| |
|
—
|
|
|
Total comprehensive loss
| |
$
|
(13,073
|
)
| |
$
|
(11,216
|
)
|
| | | | | |
|
|
Basic and diluted net loss per common share
| |
$
|
(0.14
|
)
| |
$
|
(0.15
|
)
|
|
Basic and diluted weighted-average shares outstanding
| |
|
93,905,880
|
| |
|
77,324,890
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20170504006668/en/
Senseonics Holdings, Inc.
INVESTOR CONTACT
R. Don Elsey
Chief
Financial Officer
301-556-1602
[email protected]
Source: Senseonics Holdings, Inc.