Senseonics Holdings, Inc. Reports Fourth Quarter and Full Year 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 fourth quarter and
full year ended December 31, 2018.
RECENT HIGHLIGHTS & ACCOMPLISHMENTS:
-
Received positive reimbursement decisions for Eversense®
from several payors with coverage reaching approximately 60 million
lives in the U.S.
-
Obtained Regulatory approval to expand Eversense certification to
Nurse Practitioners and Physician Assistants, both in the U.S. and
Europe
-
Commenced the PROMISE 180-day sensor clinical study in the U.S.
-
Submitted a PMA supplement to the FDA seeking to secure an insulin
dosing claim for Eversense
-
Extended Roche distribution agreement through January 2021 while
expanding to an additional 17 countries, including Brazil, Russia,
India and China
-
Appointed Jon D. Isaacson as Chief Financial Officer and Dr. Francine
Kaufman as Chief Medical Officer
“We are pleased with 2018 which was a milestone year for Senseonics
highlighted by FDA approval of the Eversense system, the build out of
our commercial organization, and continued penetration in Europe” said
Tim Goodnow, President and Chief Executive Officer of Senseonics. “We
continue to learn and adapt from the launch of this highly innovative
product and expect real-world experience to drive patient and clinician
demand for Eversense. With additional coverage policy wins and raising
awareness of the benefits of a long-term implantable CGM, we are
confident we have the strategy and team in place to accelerate adoption
and help more patients manage their diabetes.”
FOURTH QUARTER 2018 RESULTS:
Revenue was $7.2 million for the fourth quarter of 2018, compared to
$2.9 million for the fourth quarter of 2017.
Fourth quarter 2018 sales and marketing expenses increased $7.9 million
year-over year, to $10.3 million. The increase in sales and marketing
expenses was primarily driven by an increase in compensation expenses
associated with new hires supporting the commercial launch of Eversense
in the U.S. and to support and expand the distribution of Eversense®
XL in Europe.
Fourth quarter 2018 research and development expenses decreased $0.3
million year-over-year, to $8.1 million. The decrease in research and
development expenses was primarily driven by the completion of all
activities associated with the U.S. PMA approval, including preparation
for the FDA panel held in the first quarter of 2018.
Fourth quarter 2018 general and administrative expenses increased $1.5
million, year-over-year, to $5.3 million. The increase in general and
administrative expenses was primarily driven by an increase in
compensation, legal and other administrative expenses associated with
supporting operational growth.
Net loss was $7.3 million, or $0.04 per share, in the fourth quarter of
2018, compared to $16.3 million, or $0.12 per share, in the fourth
quarter of 2017. Fourth quarter 2018 net loss per share was based on
176.9 million weighted average shares outstanding, compared to 136.8
million weighted average shares outstanding in the fourth quarter of
2017.
FULL YEAR 2018 RESULTS:
Revenue for the year ended December 31, 2018 was $18.9 million, compared
to $6.4 million in 2017.
Sales and marketing expenses for the year ended December 31, 2018
increased $20.8 million year-over year, to $27.7 million, compared to
$6.9 million for 2017. The increase in sales and marketing expenses was
primarily related to investments in additional headcount to support the
U.S. commercial launch of Eversense and support of the expanding
commercial efforts for Eversense XL in Europe.
Research and development expenses for the year ended December 31, 2018
increased $1.2 million year-over-year, to $31.9 million, compared to
$30.7 million for 2017. The increase in research and development
expenses was primarily driven by product development expenses for future
versions of Eversense and clinical trial costs related to the PMA
approval of Eversense in the U.S.
General and administrative expenses for the year ended December 31, 2018
increased $4.5 million, year-over-year, to $19.8 million, compared to
$15.3 million for 2017. The increase in general and administrative
expenses was driven primarily by an increase in personnel-related
expenses, increased facility expenses and increased legal and audit
expenses.
Net loss was $94.0 million, or $0.60 per share, for the year ended
December 31, 2018, compared to $59.1 million, or $0.51 per share, for
2017. Net loss per share for 2018 was based on 157.4 million weighted
average shares outstanding, compared to 116.0 million weighted average
shares outstanding for 2017.
As of December 31, 2018, cash and cash equivalents were $136.8 million
and outstanding indebtedness was $67.7 million.
2019 Financial Outlook
Management updates its projected revenue for full year 2019 to be in the
range of $25 to $30 million.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 4:30 pm (Eastern Time)
today, March 12, 2019, to discuss these financial results and recent
business developments. 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® XL CGM 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 expanded
relationship with Roche, the potential commercialization of Eversense in
additional markets, Senseoncis’ projected revenue for full year 2019,
the ongoing commercialization of Eversense in the U.S. and Eversense XL
in Europe, the acceleration of the adoption of Eversense, growing
patient and clinician demand for Eversense, and the potential
life-enhancing benefits Eversense offers people with diabetes, and other
statements containing the words “believe,” “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 commercial
launch and commercial expansion of the product, 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. |
|
|
Unaudited Condensed Consolidated Balance Sheets |
| (in thousands, except share and per share data) |
|
| |
| | December 31, |
| | 2018 |
| 2017 |
| Assets | | | | | | |
|
Current assets:
| | | | | | |
|
Cash and cash equivalents
| |
$
|
136,793
| | |
$
|
16,150
| |
|
Marketable securities
| | |
—
| | | |
20,300
| |
|
Accounts receivable, primarily from a related party
| | |
7,097
| | | |
3,382
| |
|
Inventory, net
| | |
10,231
| | | |
2,991
| |
|
Prepaid expenses and other current assets
| |
|
3,985
|
| |
|
2,092
|
|
|
Total current assets
| | |
158,106
| | | |
44,915
| |
| | | | | |
|
|
Deposits and other assets
| | |
117
| | | |
176
| |
|
Property and equipment, net
| |
|
1,750
|
| |
|
853
|
|
|
Total assets
| |
$
|
159,973
|
| |
$
|
45,944
|
|
| | | | | |
|
| Liabilities and Stockholders’ Equity | | | | | | |
|
Current liabilities:
| | | | | | |
|
Accounts payable
| |
$
|
4,407
| | |
$
|
7,712
| |
|
Accrued expenses and other current liabilities
| | |
13,851
| | | |
5,428
| |
|
Deferred Revenue
| | |
628
| | | |
—
| |
|
Notes payable, current portion
| |
|
10,000
|
| |
|
10,000
|
|
|
Total current liabilities
| | |
28,886
| | | |
23,140
| |
| | | | | |
|
|
Notes payable, net of discount
| | |
4,783
| | | |
14,414
| |
|
Convertible senior notes, net of discount
| | |
36,103
| | | |
—
| |
|
Derivative liability
| | |
17,091
| | | |
—
| |
|
Notes payable, accrued interest
| | |
1,764
| | | |
1,054
| |
|
Other liabilities
| |
|
85
|
| |
|
69
|
|
|
Total liabilities
| | |
88,712
| | | |
38,677
| |
| | | | | |
|
|
Commitments and contingencies (Note 9)
| | | | | | |
| | | | | |
|
|
Stockholders’ equity:
| | | | | | |
Common stock, $0.001 par value per share; 450,000,000 and
250,000,000 shares authorized as of December 31, 2018 and 2017;
176,918,381 and 136,882,735 shares issued and outstanding as of
December 31, 2018 and 2017
| | |
177
| | | |
137
| |
|
Additional paid-in capital
| | |
428,878
| | | |
270,953
| |
|
Accumulated deficit
| |
|
(357,794
|
)
| |
|
(263,823
|
)
|
|
Total stockholders' equity
| |
|
71,261
|
| |
|
7,267
|
|
|
Total liabilities and stockholders’ equity
| |
$
|
159,973
|
| |
$
|
45,944
|
|
| | | | | | | |
|
| Senseonics Holdings, Inc. |
|
|
| Unaudited Condensed Consolidated Statements of Operations and
Comprehensive Income (Loss) |
| (in thousands, except share and per share data) |
|
| |
| | Years Ended |
| | December 31, |
| | 2018 |
| 2017 |
| 2016 |
|
Revenue, primarily from a related party
| |
$
|
18,913
| | |
$
|
6,373
| | |
$
|
332
| |
|
Cost of sales
| |
|
27,059
|
| |
|
9,758
|
| |
|
660
|
|
|
Gross profit
| | |
(8,146
|
)
| | |
(3,385
|
)
| | |
(328
|
)
|
| | | | | | | | |
|
|
Expenses:
| | | | | | | | | |
|
Sales and marketing expenses
| | |
27,730
| | | |
6,857
| | | |
2,736
| |
|
Research and development expenses
| | |
31,863
| | | |
30,735
| | | |
26,347
| |
|
General and administrative expenses
| |
|
19,839
|
| |
|
15,336
|
| |
|
13,022
|
|
|
Operating loss
| | |
(87,578
|
)
| | |
(56,313
|
)
| | |
(42,433
|
)
|
|
Other income (expense), net:
| | | | | | | | | |
|
Interest income
| | |
2,001
| | | |
135
| | | |
80
| |
|
Interest expense
| | |
(8,282
|
)
| | |
(3,099
|
)
| | |
(1,602
|
)
|
|
Change in fair value of derivative liability
| | |
209
| | | |
—
| | | |
—
| |
|
Other (expense) income
| |
|
(321
|
)
| |
|
176
|
| |
|
25
|
|
|
Total other expense, net
| | |
(6,393
|
)
| | |
(2,788
|
)
| | |
(1,497
|
)
|
| | | | | | | | |
|
|
Net loss
| | |
(93,971
|
)
| | |
(59,101
|
)
| | |
(43,930
|
)
|
|
Total comprehensive loss
| |
$
|
(93,971
|
)
| |
$
|
(59,101
|
)
| |
$
|
(43,930
|
)
|
| | | | | | | | |
|
|
Basic and diluted net loss per common share
| |
$
|
(0.60
|
)
| |
$
|
(0.51
|
)
| |
$
|
(0.49
|
)
|
|
Basic and diluted weighted-average shares outstanding
| |
|
157,429,145
|
| |
|
115,975,402
|
| |
|
89,243,853
|
|
| | | | | | | | | | | |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190312005859/en/
INVESTOR CONTACT
Lynn Lewis or Philip Taylor
Investor
Relations
415-937-5406
[email protected]
Source: Senseonics Holdings, Inc.