Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and commercialization
of long-term, implantable continuous glucose monitoring (CGM)
systems for people with diabetes, today reported financial results
for the quarter ended September 30, 2021.
Recent Highlights & Accomplishments:
- Generated third quarter 2021 revenue of $3.5 million
- FDA active review of the Eversense® 180-day PMA supplement
application continues
- Presented clinical data on the safety and accuracy of Eversense
at the European Association for the Study of Diabetes Annual
Meeting, Association of Diabetes Care & Education Specialists
Annual Conference and the Diabetes Technology Meeting
“In the third quarter we remained laser focused on advancing the
most innovative pipeline in CGM while Ascensia progressed
initiatives to drive Eversense patient adoption,” said Tim Goodnow,
PhD, President and Chief Executive Officer of Senseonics. “We are
encouraged by the excitement demonstrated by patients and HCPs for
the 180-day sensor in the US and we are pleased with the
progression of the review and are hopeful the FDA will reach an
approval decision in the coming months based on the positive
PROMISE Study results. We look forward to launching the new system
shortly after approval.”
Third Quarter 2021 Results:
Total revenue for the third quarter was $3.5 million compared to
$0.8 million for the third quarter of 2020. This increase was due
to the transition of commercial responsibility for Eversense to
Ascensia and its orders for distribution in the European Union and
in the United States. U.S. revenue was $0.6 million and revenue
outside the U.S. was $2.9 million.
Third quarter 2021 gross loss declined by $2.1 million
year-over-year, to $1.2 million.
Third quarter 2021 sales and marketing expenses decreased by
$0.7 million year-over-year, to $2.5 million. The decrease was
primarily the result of a decline in salary and personnel costs
from the reduction in sales support due to the transition to
Ascensia for the commercialization of Eversense, offset by an
increase in general advertising related to the shared support of
the commercialization of the 90-day product in the US.
Third quarter 2021 research and development expenses increased
by $2.6 million year-over-year, to $7.2 million. The increase was
due to higher salaries and related expenses from the expansion of
R&D workforce, an increase in clinical studies and lab
supplies, and an increase in contractor expenses.
Third quarter 2021 general and administrative expenses decreased
by $0.4 million year-over-year, to $5.12 million. The decrease was
due to lower legal expenses and a decrease in other administrative
costs including investor relations costs for the annual meeting,
accounting fees, and other general administrative expenses.
Net income was $42.9 million, or $0.10 per share, in the third
quarter of 2021, compared to a net loss of $23.4 million, or
($0.10) per share, in the third quarter of 2020. Net income
increased by $66.3 million due to the accounting for embedded
derivatives and fair value adjustments.
As of September 30, 2021, cash, cash equivalents, short and
long-term investments were $201.1 million and outstanding
indebtedness was $109.1 million.
2021 Financial Outlook
COVID-19 continues to pose a risk of uncertainty to the
Company’s overall business and the FDA’s review of our 180-day
product PMA supplement application. As a result, Senseonics
currently expects its full year 2021 global net revenue to be in
the middle of the revenue guidance range of $12.0 million to $15.0
million.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, November 9, 2021, to discuss these financial
results and recent business developments. This conference call can
be accessed live by telephone or through Senseonics’ website.
Live
Teleconference Information:
Dial in number: 888-317-6003
Entry Number: 6493474
International dial in: 412-317-6061
Live Webcast
Information:
Visit http://www.senseonics.com and select
the “Investor Relations” section
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 the revenue
projections under “2021 Financial Outlook,” statements about the
potential benefits of the Ascensia commercialization and
collaboration agreement, including the ability of Ascensia to grow
the market for Eversense, the future increase in patient and
provider awareness of Eversense, reductions in patient costs and
expansion of access to Eversense, and other statements containing
the words “believe,” “expect,” “intend,” “may,” “projects,” “will,”
“planned,” 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 and timing for the 180-day Eversense
product, uncertainties inherent in the commercial launch and
commercial expansion of the Eversense product, uncertainties
inherent in the transition of commercialization responsibilities to
Ascensia, uncertainties in insurer, regulatory and administrative
processes and decisions, uncertainties in the duration and severity
of the COVID-19 pandemic, 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, 2020, Senseonics’ Quarterly
Report on Form 10-Q for the quarter ended June 30, 2021 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.
Senseonics Holdings,
Inc.
Condensed Consolidated Balance
Sheets
(in thousands, except share
and per share data)
September 30,
December 31,
2021
2020
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
46,211
$
18,005
Restricted cash
—
200
Short term investments, net
96,566
—
Accounts receivable, net
124
565
Accounts receivable - related parties
3,549
2,421
Inventory, net
7,878
5,281
Prepaid expenses and other current
assets
3,732
3,774
Total current assets
158,060
30,246
Option
236
1,886
Deposits and other assets
1,668
2,229
Long term investments, net
58,355
—
Property and equipment, net
1,305
1,557
Total assets
$
219,624
$
35,918
Liabilities and Stockholders’
Deficit
Current liabilities:
Accounts payable
$
793
$
1,762
Accrued expenses and other current
liabilities
13,985
11,674
Term Loans, net
5,113
3,202
Total current liabilities
19,891
16,638
Long-term debt and notes payables, net
57,161
57,216
Derivative liabilities
317,304
62,119
Option
91,097
39,734
Other liabilities
817
1,483
Total liabilities
486,270
177,190
Preferred stock and additional
paid-in-capital, subject to possible redemption: $0.001 par value
per share; 0 shares issued and outstanding as of September 30, 2021
and 3,000 shares issued and outstanding as of December 31, 2020
—
2,811
Total temporary equity
—
2,811
Commitments and contingencies
Stockholders’ deficit:
Common stock, $0.001 par value per share;
900,000,000 shares authorized; 445,615,196 and 265,582,688 shares
issued and outstanding as of September 30, 2021 and December 31,
2020
446
266
Additional paid-in capital
768,324
504,162
Accumulated other comprehensive income,
net of tax
2
—
Accumulated deficit
(1,035,418
)
(648,511
)
Total stockholders' deficit
(266,646
)
(144,083
)
Total liabilities and stockholders’
deficit
$
219,624
$
35,918
The accompanying notes are an
integral part of these unaudited condensed consolidated financial
statements.
Senseonics Holdings,
Inc.
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share
and per share data)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Revenue, net
$
276
514
1,196
761
Revenue, net - related parties
3,256
253
8,471
303
Total revenue
3,532
767
9,667
1,064
Cost of sales
4,778
(68
)
9,995
21,006
Gross profit (loss)
(1,246
)
835
(328
)
(19,942
)
Expenses:
Sales and marketing expenses
2,468
3,234
5,725
17,521
Research and development expenses
7,200
4,568
19,562
15,726
General and administrative expenses
5,117
5,501
17,622
15,635
Operating loss
(16,031
)
(12,468
)
(43,237
)
(68,824
)
Other income (expense), net:
Interest income
486
1
743
173
Gain (Loss) on fair value adjustment of
option
13,556
—
(74,848
)
—
Gain (Loss) on extinguishment of debt and
option
—
(9,527
)
330
(20,458
)
Loss on issuance of debt & other
issuance costs
—
(931
)
—
(1,216
)
Interest expense
(4,245
)
(3,632
)
(12,337
)
(11,560
)
Gain (Loss) on change in fair value of
derivatives
50,075
3,520
(255,185
)
29,069
Impairment cost
(488
)
—
(1,650
)
—
Other expense
(439
)
(391
)
(723
)
(720
)
Total other income (expense), net
58,945
(10,960
)
(343,670
)
(4,712
)
Net Income (Loss)
42,914
(23,428
)
(386,907
)
(73,536
)
Other comprehensive income, net of tax
Unrealized gain on marketable
securities
18
—
2
—
Total other comprehensive income, net of
tax
18
—
2
—
Total comprehensive income (loss), net of
tax
$
42,932
$
(23,428
)
$
(386,905
)
$
(73,536
)
Basic net income (loss) per common
share
$
0.10
$
(0.10
)
$
(0.93
)
$
(0.33
)
Basic weighted-average shares
outstanding
445,378,308
236,519,812
414,128,283
220,250,060
Diluted net income (loss) per common
share
$
0.08
$
(0.10
)
$
(0.93
)
$
(0.33
)
Diluted weighted-average shares
outstanding
581,760,516
236,519,812
414,128,283
220,250,060
The accompanying notes are an
integral part of these unaudited condensed consolidated financial
statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211109006470/en/
Investor Contact Lynn Lewis or Philip Taylor Investor
Relations 415-937-5406 Investors@senseonics.com
Senseonics Media Contact: Mirasol Panlilio
301-556-1631
Senseonics (AMEX:SENS)
Historical Stock Chart
From May 2024 to Jun 2024
Senseonics (AMEX:SENS)
Historical Stock Chart
From Jun 2023 to Jun 2024