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 June 30, 2023.
Recent Highlights & Accomplishments:
- Generated revenue of $4.1 million in the second quarter of
2023
- Submitted an application to the FDA for an iCGM designation for
the Eversense CGM system
- Received a positive coverage decision from UnitedHealthcare,
the largest healthcare insurance company in the United States, for
the Eversense E3 CGM, expanding access to a total of approximately
300 million covered lives
- Expanded the NPG sensor inserter network providing patients
with further convenient options to start Eversense
- Presented positive data at the American Diabetes Association
83rd Scientific Sessions highlighting 365 day longevity and
accuracy of the Eversense System
- Entered into a series of exchange agreements to exchange up to
$30.8 million in principal amount of the 2025 Notes for a
combination of cash and stock, further strengthening the balance
sheet
“In the second quarter, we continued to execute on our strategic
priorities of advancing our product pipeline and collaborating with
Ascensia Diabetes Care, our global commercial partner. The FDA
submission for the iCGM designation and the expansion of both
Ascensia’s dedicated U.S. CGM salesforce and the NPG partnership
support our drive to increase patient and provider adoption of our
Eversense System,” said Tim Goodnow, PhD, President and Chief
Executive Officer of Senseonics. “Additionally, we are pleased with
the positive data readouts presented at ADA, demonstrating that our
current sensor configuration delivered accurate results for 365
days. This data gives us confidence in the execution of our product
pipeline, and we are looking forward to the next generation
products which we expect to further support ADC’s efforts to build
the Eversense brand and drive global adoption.”
Second Quarter 2023 Results:
Total revenue for the second quarter of 2023 was $4.1 million
compared to $3.7 million for the second quarter of 2022. U.S.
revenue was $1.8 million in the second quarter of 2023 compared to
$1.2 million in the prior year period, and revenue outside the U.S.
was $2.3 million in the second quarter of 2023 compared to $2.5
million in the prior year period.
Second quarter 2023 gross profit of $0.4 million decreased from
$0.8 million in gross profit for the second quarter of 2022. The
reduction in gross margin was primarily driven by an increase in
the revenue share percentage due to Ascensia.
Second quarter 2023 sales and marketing and general and
administrative expenses decreased by $1.1 million year-over-year,
to $7.5 million. The decrease was the result of reduced personnel
costs and other general and administrative costs.
Second quarter 2023 research and development expenses increased
by $3.5 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 $20.4 million, or $0.04 per share, in the second
quarter of 2023 compared to a net income of $104.2 million, or
$0.22 per share, in the second quarter of 2022. The change in net
income was due to the accounting for embedded derivatives, fair
value adjustments and the exchange of the PHC notes last
quarter.
Cash, cash equivalents, short and long-term investments were
$125.1 million and outstanding indebtedness was $52.4 million as of
June 30, 2023.
2023 Financial Outlook
Senseonics reiterates the expectation for full year 2023 global
net revenue to be in the range of $20 million to $24 million.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, August 10, 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: 2402364
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 collaborating with a new partner in 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, the ability to successfully complete the exchanges of
2025 Notes 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 June 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)
June 30,
December 31,
2023
2022
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
28,551
$
35,793
Short term investments, net
89,067
108,222
Accounts receivable, net
655
127
Accounts receivable, net - related
parties
3,020
2,324
Inventory, net
9,194
7,306
Prepaid expenses and other current
assets
7,742
7,428
Total current assets
138,229
161,200
Deposits and other assets
6,755
3,108
Long term investments, net
7,453
12,253
Property and equipment, net
925
1,112
Total assets
$
153,362
$
177,673
Liabilities and Stockholders’ Equity
(Deficit)
Current liabilities:
Accounts payable
$
975
$
419
Accrued expenses and other current
liabilities
14,256
14,616
Accrued expenses and other current
liabilities, related parties
630
837
Note payable, current portion, net
—
15,579
Derivative liability, current portion
—
20
Total current liabilities
15,861
31,471
Long-term debt and notes payables, net
39,108
56,383
Derivative liabilities
1,792
52,050
Other liabilities
6,408
2,689
Total liabilities
63,169
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 June 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 June 30, 2023 and December 31,
2022; 492,826,683 shares and 479,637,138 shares issued and
outstanding as of June 30, 2023 and December 31, 2022
493
480
Additional paid-in capital
880,129
806,488
Accumulated other comprehensive loss
(120
)
(678
)
Accumulated deficit
(827,965
)
(808,866
)
Total stockholders’ equity (deficit)
52,537
(2,576
)
Total liabilities and stockholders’
equity
$
153,362
$
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
Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
Revenue, net
$
437
137
$
750
$
429
Revenue, net - related parties
3,689
3,577
7,513
5,767
Total revenue
4,126
3,714
8,263
6,196
Cost of sales
3,709
2,890
7,433
4,845
Gross profit
417
824
830
1,351
Expenses:
Research and development expenses
12,830
9,299
25,235
17,103
Selling, general and administrative
expenses
7,455
8,561
15,173
16,445
Operating loss
(19,868
)
(17,036
)
(39,578
)
(32,197
)
Other income (expense), net:
Interest income
1,311
241
2,420
334
Gain on fair value adjustment of
option
—
28,224
—
49,925
Exchange related gain, net
—
—
18,776
—
Interest expense
(2,310
)
(4,510
)
(6,962
)
(9,005
)
Gain on change in fair value of
derivatives
289
96,548
6,067
181,117
Impairment cost, net
—
816
—
846
Other income (expense)
155
(52
)
178
(71
)
Total other (expense) income, net
(555
)
121,267
20,479
223,146
Net (Loss) Income
(20,423
)
104,231
(19,099
)
190,949
Other comprehensive income (loss)
Unrealized gain (loss) on marketable
securities
100
(291
)
558
(916
)
Total other comprehensive gain (loss)
100
(291
)
558
(916
)
Total comprehensive (loss) income
$
(20,323
)
$
103,940
$
(18,541
)
$
190,033
Basic net (loss) income per common
share
$
(0.04
)
0.22
$
(0.04
)
$
0.42
Basic weighted-average shares
outstanding
567,125,022
464,133,903
532,499,776
460,061,022
Diluted net loss per common share
$
(0.04
)
(0.03
)
$
(0.04
)
$
(0.06
)
Diluted weighted-average shares
outstanding
567,125,022
601,330,959
532,499,776
604,342,540
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230810289381/en/
Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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