Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and manufacturing of
long-term, implantable continuous glucose monitoring (CGM) systems
for people with diabetes, today reported financial results for the
quarter ended September 30, 2023.
Recent Highlights & Accomplishments:
- Generated revenue of $6.1 million in the third quarter of
2023
- Announced the last patient completion of the 365-day ENHANCE
Pivotal Clinical Study adult cohort
- Launched with our global commercial partner Ascensia Diabetes
Care, a new direct to consumer U.S. advertising campaign, ‘The CGM
for Real Life’ to increase awareness of Eversense’s unique
benefits
- Entered into a $50 million non-dilutive loan facility with
Hercules Capital, Inc. and drew down an initial $25 million,
further strengthening the balance sheet
“The third quarter was marked by milestones across our
development programs, commercial collaboration with Ascensia, and
continued progress in strengthening our balance sheet,” said Tim
Goodnow, PhD, President and Chief Executive Officer of Senseonics.
“Completing the adult cohort of the ENHANCE 365-day pivotal trial,
launching a new advertising campaign and finalizing a new loan
facility all help position us to advance our plans to grow adoption
of Eversense, the world’s only long term CGM.”
Third Quarter 2023 Results:
Total revenue for the third quarter of 2023 was $6.1 million
compared to $4.6 million for the third quarter of 2022. U.S.
revenue was $3.9 million in the third quarter of 2023 compared to
$1.9 million in the prior year period, and revenue outside the U.S.
was $2.2 million in the third quarter of 2023 compared to $2.7
million in the prior year period.
Third quarter 2023 gross profit of $1.2 million increased from
$0.8 million in gross profit for the third quarter of 2022. The
increase in gross margin was primarily driven by an increase to
revenue as volumes increased.
Third quarter 2023 sales and marketing and general and
administrative expenses increased by $0.1 million year-over-year,
to $7.4 million. The consistency was the result of efforts to
manage other general and administrative costs across the
organization.
Third quarter 2023 research and development expenses increased
by $1.8 million year-over-year, to $12.8 million. The increase was
primarily due to investments in our product pipeline for
development and clinical trials of next generation
technologies.
Net loss was $24.1 million, or $0.04 per share, in the third
quarter of 2023 compared to a net loss of $60.4 million, or $0.13
per share, in the third quarter of 2022. Net income increased by
$36.3 million due to the accounting for embedded derivatives, fair
value adjustments and the exchange of a portion of the 2025
notes.
Cash, cash equivalents, short and long-term investments were
$125.4 million and outstanding indebtedness was $45.8 million as of
September 30, 2023.
2023 Financial Outlook
Senseonics expects full year 2023 global net revenue to be at
the midpoint of the $20 million to $24 million range.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, November 9, 2023, 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: 1409312
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. ("Senseonics") is a medical technology
company focused on the development and manufacturing of glucose
monitoring products designed to transform lives in the global
diabetes community with differentiated, long-term implantable
glucose management technology. Senseonics' CGM systems, Eversense®,
Eversense® XL and Eversense® E3 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 "2023 Financial Outlook," statements about the
commercial launch of Eversense® E3, statements regarding increasing
patient access and patient and provider adoption, statements
regarding advancing development programs and the pipeline,
statements regarding strengthening the Eversense® brand, 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 inherent in the commercial launch of Eversense® E3
CGM system and commercial expansion of the Eversense product,
uncertainties inherent in the expansion of Ascensia Diabetes Care’s
U.S. salesforce and its commercial initiatives, uncertainties
inherent in partnering with the Nurse Practitioner Group and that
partner’s assumption of certain clinical and administrative
activities, uncertainties in insurer, regulatory and administrative
processes and decisions, uncertainties inherent in the development
and registration of new technology, uncertainties relating to the
current economic environment 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, 2022, the Quarterly
Report on Form 10-Q for the quarter ended September 30, 2023 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,
2023
2022
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
55,759
$
35,793
Short term investments, net
69,648
108,222
Accounts receivable, net
701
127
Accounts receivable, net - related
parties
2,749
2,324
Inventory, net
9,726
7,306
Prepaid expenses and other current
assets
7,557
7,428
Total current assets
146,140
161,200
Deposits and other assets
6,991
3,108
Long term investments, net
—
12,253
Property and equipment, net
934
1,112
Total assets
$
154,065
$
177,673
Liabilities and Stockholders’ Equity
(Deficit)
Current liabilities:
Accounts payable
$
2,669
$
419
Accrued expenses and other current
liabilities
14,356
14,616
Accrued expenses and other current
liabilities, related parties
277
837
Note payable, current portion, net
—
15,579
Derivative liability, current portion
—
20
Total current liabilities
17,302
31,471
Long-term debt and notes payables, net
40,485
56,383
Derivative liabilities
245
52,050
Other liabilities
6,312
2,689
Total liabilities
64,344
142,593
Preferred stock and additional
paid-in-capital, subject to possible redemption: $0.001 par value
per share; 12,000 shares and 12,000 shares issued and outstanding
as of September 30, 2023 and December 31, 2022
37,656
37,656
Total temporary equity
37,656
37,656
Commitments and contingencies
Stockholders’ equity (deficit):
Common stock, $0.001 par value per share;
900,000,000 shares authorized as of September 30, 2023 and December
31, 2022; 528,176,273 shares and 479,637,138 shares issued and
outstanding as of September 30, 2023 and December 31, 2022
528
480
Additional paid-in capital
903,665
806,488
Accumulated other comprehensive loss
(59
)
(678
)
Accumulated deficit
(852,069
)
(808,866
)
Total stockholders’ equity (deficit)
52,065
(2,576
)
Total liabilities and stockholders’
equity
$
154,065
$
177,673
Senseonics Holdings,
Inc.
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive Income
(Loss)
(in thousands, except share
and per share data)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Revenue, net
$
426
$
126
$
1,176
$
555
Revenue, net - related parties
5,671
4,496
13,184
10,263
Total revenue
6,097
4,622
14,360
10,818
Cost of sales
4,925
3,866
12,358
8,711
Gross profit
1,172
756
2,002
2,107
Expenses:
Research and development expenses
12,769
10,985
38,003
28,088
Selling, general and administrative
expenses
7,425
7,340
22,598
23,785
Operating loss
(19,022
)
(17,569
)
(58,599
)
(49,766
)
Other income (expense), net:
Interest income
1,460
544
3,879
878
Gain (Loss) on fair value adjustment of
option
—
(8,592
)
—
41,333
Exchange related gain (loss), net
(4,569
)
—
14,207
—
Interest expense
(2,425
)
(4,801
)
(9,388
)
(13,806
)
Gain (Loss) on change in fair value of
derivatives
438
(28,948
)
6,505
152,169
Impairment cost, net
—
(984
)
—
(138
)
Other income (expense)
15
(41
)
194
(112
)
Total other (expense) income, net
(5,081
)
(42,822
)
15,397
180,324
Net (Loss) Income
(24,103
)
(60,391
)
(43,202
)
130,558
Other comprehensive income (loss)
Unrealized gain (loss) on marketable
securities
61
(57
)
619
(973
)
Total other comprehensive gain (loss)
61
(57
)
619
(973
)
Total comprehensive (loss) income
$
(24,042
)
$
(60,448
)
$
(42,583
)
$
129,585
Basic net (loss) income per common
share
$
(0.04
)
$
(0.13
)
$
(0.08
)
$
0.28
Basic weighted-average shares
outstanding
592,452,262
472,475,747
552,703,546
464,244,736
Diluted net loss per common share
$
(0.04
)
$
(0.13
)
$
(0.08
)
$
(0.10
)
Diluted weighted-average shares
outstanding
592,452,262
472,475,747
552,703,546
608,345,713
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231109303594/en/
Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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