Senseonics Holdings, Inc. Reports Third 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 third quarter ended
September 30, 2018.
RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
-
Commercially launched Eversense in the U.S. and completed first
commercial insertion
-
Announced positive coverage decision from Aetna, the third largest
commercial health plan in the U.S. providing coverage for
approximately 22 million lives
-
Received coverage from BCBS Minnesota for approximately 2.5 million
lives
-
Received FDA approval for qualified health care providers – including
nurse practitioners and physician assistants – to be trained and
certified to provide patients with Eversense
-
Received FDA approval to begin the 180-day investigational device
exemption (IDE) registration trial in the U.S.
“The third quarter was a particularly exciting time for Senseonics with
the U.S. launch of the Eversense system. Feedback from our first users
has been exceptional across both patient and healthcare professional
communities,” said Tim Goodnow, President and Chief Executive Officer of
Senseonics. “As we look ahead, we are pleased with the early progress we
are making to establish reimbursement and broaden patient and physician
access to Eversense. Simultaneously, we are continuing to develop our
clinical pipeline. We look forward to expanding our reach as we bring
this life changing technology to people with diabetes.”
THIRD QUARTER 2018 RESULTS:
Revenue was $5.2 million for the third quarter of 2018, compared to $3.6
million for the second quarter of 2018 and $2.1 million for the third
quarter of 2017.
Third quarter 2018 sales and marketing expenses was $7.9 million
compared to $6.2 million in the second quarter of 2018, and $2.1 million
in third quarter 2017. The increase in sales and marketing expenses was
primarily driven by an increase in compensation expense associated with
adding additional sales personnel to support the U.S. launch and to
continue expanding the distribution of Eversense in Europe.
Third quarter 2018 research and development expenses decreased $0.9
million compared to the second quarter of 2018 to $7.4 million and
decreased $2.4 million compared to third quarter 2017. The decrease in
research and development expenses compared to the second quarter of 2018
was primarily driven by decreases in regulatory work in support of the
FDA approval.
Third quarter 2018 general and administrative expenses were $5.1
million, a decrease of $0.3 million compared to the second quarter of
2018 and an increase of $1.2 million compared to the third quarter of
2017. The decrease in general and administration expenses compared to
the second quarter of 2018 was primarily driven by the timing of
spending associated with supporting operational growth.
Net loss was $31.9 million, or $0.18 per share, in the third quarter of
2018, compared to $17.4 million, or $0.13 per share, in the third
quarter of 2017. This compares to a second quarter 2018 net loss of
$32.5 million, or $0.23 per share. This decrease in net loss compared to
the second quarter of 2018 was driven primarily by a change in the fair
value of the derivative liability.. Excluding the change in fair value
of the derivative liability, third quarter 2018 net loss would have been
$24.4 million, or $0.14 per share. Third quarter 2018 net loss per share
was based on 176.3 million weighted average shares outstanding, compared
to 128.9 million weighted average shares outstanding in the third
quarter of 2017.
As of September 30, 2018, cash, cash equivalents, and marketable
securities were $163.0 million and outstanding indebtedness was $70.2
million.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 4:30 pm (Eastern Time)
today, November 8, 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 transformative glucose
monitoring products designed to help people with diabetes confidently
live their lives with ease. From its inception, Senseonics has been
advancing the integration of novel, fluorescence sensor technology with
smart wearable devices. The Eversense® CGM System received PMA approval
from the FDA for up to 90 days of continuous use and is available in the
United States. The Eversense® CGM XL System received CE mark for up to
180 days of continuous use and is available in Europe. For more
information on Senseonics, please visit www.senseonics.com.
FORWARD LOOKING STATEMENTS
Any statements in this press release about future expectations, plans
and prospects for Senseonics, including statements about the clinical
development of future generations of Eversense, the expanded
commercialization of Eversense and Eversense XL in Europe, additional
regulatory approvals, 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 in the
development and regulatory approval processes, 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
September 30, 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) |
|
| | |
| | |
| | September 30, | | December 31, |
| | 2018 | | 2017 |
| | | | |
|
| |
(unaudited)
| | | |
| Assets | | | | | | |
|
Current assets:
| | | | | | |
|
Cash and cash equivalents
| |
$
|
157,032
| | |
$
|
16,150
| |
|
Marketable securities
| | |
5,997
| | | |
20,300
| |
|
Accounts receivable, primarily from a related party
| | |
4,101
| | | |
3,382
| |
|
Inventory, net
| | |
10,001
| | | |
2,991
| |
|
Prepaid expenses and other current assets
| |
|
4,723
|
| |
|
2,092
|
|
|
Total current assets
| | |
181,854
| | | |
44,915
| |
| | | | | |
|
|
Deposits and other assets
| | |
119
| | | |
176
| |
|
Property and equipment, net
| |
|
1,358
|
| |
|
853
|
|
|
Total assets
| |
$
|
183,331
|
| |
$
|
45,944
|
|
| | | | | |
|
| Liabilities and Stockholders’ Equity | | | | | | |
|
Current liabilities:
| | | | | | |
|
Accounts payable
| |
$
|
3,870
| | |
$
|
7,712
| |
|
Accrued expenses and other current liabilities
| | |
8,854
| | | |
5,428
| |
|
Notes payable, current portion
| |
|
10,000
|
| |
|
10,000
|
|
|
Total current liabilities
| | |
22,724
| | | |
23,140
| |
| | | | | |
|
|
Notes payable, net of discount
| | |
7,207
| | | |
14,414
| |
|
Convertible senior notes, net of discount
| | |
35,277
| | | |
—
| |
|
Derivative liability
| | |
39,825
| | | |
—
| |
|
Notes payable, accrued interest
| | |
1,614
| | | |
1,054
| |
|
Other liabilities
| |
|
79
|
| |
|
69
|
|
|
Total liabilities
| | |
106,726
| | | |
38,677
| |
| | | | | |
|
|
Commitments and contingencies
| | | | | | |
| | | | | |
|
|
Stockholders’ equity:
| | | | | | |
|
Common stock, $0.001 par value per share; 450,000,000 and
250,000,000 shares authorized, 176,725,832 and 136,882,735 shares
issued and outstanding as of September 30, 2018 and December 31, 2017
| | |
177
| | | |
137
| |
|
Additional paid-in capital
| | |
426,901
| | | |
270,953
| |
|
Accumulated deficit
| |
|
(350,473
|
)
| |
|
(263,823
|
)
|
|
Total stockholders' equity
| |
|
76,605
|
| |
|
7,267
|
|
|
Total liabilities and stockholders’ equity
| |
$
|
183,331
|
| |
$
|
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 | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2018 | | 2017 | | 2018 | | 2017 |
|
Revenue, primarily from a related party
| |
$
|
5,158
| | |
$
|
2,097
| | |
$
|
11,728
| | |
$
|
3,464
| |
|
Cost of sales
| |
|
7,742
|
| |
|
2,957
|
| |
|
14,889
|
| |
|
5,716
|
|
|
Gross profit
| | |
(2,584
|
)
| | |
(860
|
)
| | |
(3,161
|
)
| | |
(2,252
|
)
|
| | | | | | | | | | | |
|
|
Expenses:
| | | | | | | | | | | | |
|
Sales and marketing expenses
| | |
7,851
| | | |
2,089
| | | |
17,469
| | | |
4,478
| |
|
Research and development expenses
| | |
7,402
| | | |
9,765
| | | |
23,805
| | | |
22,368
| |
|
General and administrative expenses
| |
|
5,138
|
| |
|
3,891
|
| |
|
14,531
|
| |
|
11,545
|
|
|
Operating loss
| | |
(22,975
|
)
| | |
(16,605
|
)
| | |
(58,966
|
)
| | |
(40,643
|
)
|
|
Other income (expense), net:
| | | | | | | | | | | | |
|
Interest income
| | |
820
| | | |
129
| | | |
1,245
| | | |
187
| |
|
Interest expense
| | |
(2,170
|
)
| | |
(915
|
)
| | |
(6,177
|
)
| | |
(2,365
|
)
|
|
Change in fair value of 2023 derivative
| | |
(7,513
|
)
| | |
—
| | | |
(22,526
|
)
| | |
—
| |
|
Other income (expense)
| |
|
(43
|
)
| |
|
12
|
| |
|
(226
|
)
| |
|
(5
|
)
|
|
Total other expense, net
| |
|
(8,906
|
)
| |
|
(774
|
)
| |
|
(27,684
|
)
| |
|
(2,183
|
)
|
| | | | | | | | | | | |
|
|
Net loss
| | |
(31,881
|
)
| | |
(17,379
|
)
| | |
(86,650
|
)
| | |
(42,826
|
)
|
|
Total comprehensive loss
| |
$
|
(31,881
|
)
| |
$
|
(17,379
|
)
| |
$
|
(86,650
|
)
| |
$
|
(42,826
|
)
|
| | | | | | | | | | | |
|
|
Basic and diluted net loss per common share
| |
$
|
(0.18
|
)
| |
$
|
(0.13
|
)
| |
$
|
(0.57
|
)
| |
$
|
(0.39
|
)
|
|
Basic and diluted weighted-average shares outstanding
| |
|
176,332,575
|
| |
|
128,898,682
|
| |
|
150,866,978
|
| |
|
108,959,779
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20181108005916/en/
INVESTOR CONTACT
Senseonics Holdings, Inc.
R. Don
Elsey, 301-556-1602
Chief Financial Officer
[email protected]
Source: Senseonics Holdings, Inc.