Senseonics Holdings, Inc. Reports Second 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 a long-term,
implantable continuous glucose monitoring (CGM) system for people with
diabetes, today reported financial results for the second quarter and
six months ended June 30, 2016.
RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
-
Completed the multi-center PRECISE II pivotal clinical investigation
in the United States and released topline results.
-
Secured an expanded debt facility with a total potential borrowing
limit of up to $30 million with Oxford Finance and Silicon Valley Bank
-
Commercially launched the Eversense® CGM System in Sweden with
Senseonics’ distribution partner Rubin Medical
-
Entered into a distribution agreement with Roche Diabetes Care for the
sale of the Eversense CGM System in Germany, Italy and the Netherlands.
"The second quarter was an important period for Senseonics with numerous
key milestones accomplished. We are very excited about the PRECISE II
topline study results we announced today,” said Tim Goodnow, PhD., CEO
and President of Senseonics. “We look forward to the balance of the
year, during which we intend to file our Premarket Approval to the FDA,
commercially launch Eversense in additional European countries, release
enhancements to our [mobile] app and apply for European regulatory
approval of our Gen2 smart transmitter.”
SECOND QUARTER 2016 RESULTS:
Net loss was $11.9 million, or $0.13 per share, in the second quarter of
2016, compared to $7.2 million, or $3.68 per share, in the second
quarter of 2015. Second quarter 2016 net loss per share was based on
92.7 million weighted average shares outstanding, compared to 1.9
million weighted average shares outstanding in the second quarter of
2015.
Second quarter 2016 sales and marketing expenses increased $0.3 million
year-over-year, to $0.6 million, compared to $0.3 million for the second
quarter of 2015. The increase in sales and marketing expenses was
primarily related to investments in additional headcount in advance of
the Company’s commercial launch of Eversense in Europe. On a sequential
quarter comparison, second quarter 2016 sales and marketing expense was
flat compared to the first quarter of 2016.
Second quarter 2016 research and development expenses increased $2.3
million year-over-year, to $7.5 million, compared to $5.2 million for
the second quarter of 2015. The increase in research and development
expense 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,
second quarter 2016 research and development expenses increased $1.1
million, or 17%, compared to the first quarter of 2016. The primary
driver behind this increase is the conduct of the U.S. pivotal trial.
Second quarter 2016 general and administrative expenses increased $1.9
million, year-over-year, to $3.4 million, compared to $1.5 million for
the second quarter of 2015. The increase in general and administration
expenses was driven primarily by salaries and related costs, including
non-cash stock-based compensation for additional headcount to support
operations as a public company. On a sequential quarter comparison,
second quarter 2016 general and administrative expenses decreased $0.5
million, or 13%, compared to the first quarter of 2016. The primary
driver of this decrease was a $0.5 million decrease in non-cash
stock-based compensation expense.
As of June 30, 2016, cash and equivalents were $36.2 million and
outstanding indebtedness was $15 million, compared to cash and
equivalents of $3.9 million and outstanding indebtedness of $10 million,
as of December 31, 2015. In June 2016, the Company entered into a new
term loan agreement with Oxford Finance and Silicon Valley Bank. This
facility has a total borrowing capacity of up to $30 million, $15
million of which was drawn upon the completion of the agreement. The
previous term loan agreement with Oxford was repaid with a portion of
the proceeds from the new borrowings.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 4:30 pm (Eastern Time)
today, August 9, 2016, 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 commercial launch of Eversense, future regulatory filings
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 19, 2016, the Quarterly Report on Form 10-Q filed with
the SEC on May 12, 2016 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. While
Senseonics may elect to update these forward-looking statements publicly
at some point in the future, Senseonics specifically disclaims any
obligation to do so, whether as a result of new information, future
events or otherwise, except as required by law.
FINANCIAL STATEMENTS TO FOLLOW:
|
|
Senseonics Holdings, Inc.
Condensed Consolidated Balance Sheets (in thousands) |
|
|
|
|
| | | |
|
| | | |
| | | June 30, | | | December 31, |
| | | 2016 | | | 2015 |
| | |
(unaudited)
| | | | | |
| Assets | | | | | | | | | | |
|
Current assets:
| | | | | | | | | | |
|
Cash and cash equivalents
| | |
$
|
36,190
| | | |
$
|
3,939
| |
|
Prepaid expenses and other current assets
| | | |
911
| | | | |
1,025
| |
|
Inventory
| | |
|
324
|
| | |
|
—
|
|
|
Total current assets
| | | |
37,425
| | | | |
4,964
| |
| | | | | | | | | |
|
|
Deposits and other assets
| | | |
648
| | | | |
217
| |
|
Property and equipment, net
| | |
|
611
|
| | |
|
311
|
|
|
Total assets
| | |
$
|
38,684
|
| | |
$
|
5,492
|
|
| | | | | | | | | |
|
| Liabilities and Stockholders’ Equity (Deficit) | | | | | | | | | | |
|
Current liabilities:
| | | | | | | | | | |
|
Accounts payable
| | |
$
|
5,092
| | | |
$
|
1,252
| |
|
Accrued expenses and other current liabilities
| | | |
4,475
| | | | |
3,694
| |
|
Note payable, current portion
| | |
|
—
|
| | |
|
2,389
|
|
|
Total current liabilities
| | | |
9,567
| | | | |
7,335
| |
| | | | | | | | | |
|
|
Note payable, net of discount
| | | |
14,619
| | | | |
7,499
| |
|
Accrued interest
| | | |
—
| | | | |
327
| |
|
Deferred rent
| | |
|
40
|
| | |
|
28
|
|
|
Total liabilities
| | |
|
24,226
|
| | |
|
15,189
|
|
| | | | | | | | | |
|
|
Commitments and contingencies
| | | | | | | | | | |
| | | | | | | | | |
|
|
Stockholders’ equity (deficit):
| | | | | | | | | | |
|
Preferred stock, $0.001 par value per share; 5,000,000 and 0 shares
authorized, no shares issued and outstanding as of June 30, 2016 and
December 31, 2015
| | | |
—
| | | | |
—
| |
|
Common stock, $0.001 par value per share; 250,000,000 shares
authorized, 93,368,011 and 75,760,061 shares issued and outstanding
as of June 30, 2016 and December 31, 2015
| | | |
93
| | | | |
76
| |
|
Additional paid-in capital
| | | |
198,235
| | | | |
151,019
| |
|
Accumulated deficit
| | |
|
(183,870
|
)
| | |
|
(160,792
|
)
|
|
Total stockholders’ equity (deficit)
| | |
|
14,458
|
| | |
|
(9,697
|
)
|
|
Total liabilities and stockholders’ equity (deficit)
| | |
$
|
38,684
|
| | |
$
|
5,492
|
|
| | | | | | | | | |
|
|
|
Senseonics Holdings, Inc.
Unaudited Condensed Consolidated Statement of Operations (in thousands) |
|
|
|
|
| | | |
|
| | | |
|
| | | |
|
| | | |
| | | Three Months Ended | | | Six Months Ended |
| | | June 30, | | | June 30, |
| | | 2016 | | | 2015 | | | 2016 | | | 2015 |
|
Revenue
| | |
$
|
19
| | | |
$
|
23
| | | |
$
|
19
| | | |
$
|
38
| |
|
Cost of sales
| | |
|
34
|
| | |
|
—
|
| | |
|
34
|
| | |
|
—
|
|
|
Gross profit
| | | |
(15
|
)
| | | |
23
| | | | |
(15
|
)
| | | |
38
| |
| | | | | | | | | | | | | | | | | | | |
|
|
Expenses:
| | | | | | | | | | | | | | | | | | | | |
|
Sales and marketing expenses
| | | |
635
| | | | |
258
| | | | |
1,268
| | | | |
590
| |
|
Research and development expenses
| | | |
7,539
| | | | |
5,195
| | | | |
13,955
| | | | |
8,860
| |
|
General and administrative expenses
| | | |
3,361
| | | | |
1,478
| | | | |
7,241
| | | | |
2,895
| |
| | |
|
|
| | |
|
|
| | |
|
|
| | |
|
|
|
|
Operating loss
| | | |
(11,550
|
)
| | | |
(6,908
|
)
| | | |
(22,479
|
)
| | | |
(12,307
|
)
|
|
Other income (expense), net:
| | | | | | | | | | | | | | | | | | | | |
|
Interest income
| | | |
31
| | | | |
2
| | | | |
34
| | | | |
3
| |
|
Interest expense
| | | |
(268
|
)
| | | |
(265
|
)
| | | |
(544
|
)
| | | |
(568
|
)
|
|
Other expense
| | | |
(74
|
)
| | | |
(14
|
)
| | | |
(89
|
)
| | | |
(5
|
)
|
| | |
|
|
| | |
|
|
| | |
|
|
| | |
|
|
|
|
Net loss
| | |
$
|
(11,861
|
)
| | |
$
|
(7,185
|
)
| | |
$
|
(23,078
|
)
| | |
$
|
(12,877
|
)
|
| | | | | | | | | | | | | | | | | | | |
|
|
Basic and diluted net loss per common share
| | |
$
|
(0.13
|
)
| | |
$
|
(3.68
|
)
| | |
$
|
(0.27
|
)
| | |
$
|
(6.63
|
)
|
|
Basic and diluted weighted-average shares outstanding
| | |
|
92,742,097
|
| | |
|
1,950,399
|
| | |
|
85,033,493
|
| | |
|
1,942,287
|
|
| | | | | | | | | | | | | | | | | | | |
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160809006382/en/
Senseonics Holdings, Inc.
INVESTOR CONTACT
R. Don Elsey
Chief
Financial Officer
301.556.1602
[email protected]
Source: Senseonics Holdings, Inc.