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 March 31, 2024.
Recent Highlights & Accomplishments:
- Generated revenue of $5.1 million in the first quarter of 2024,
representing growth of 22% compared to the prior year period
- Announced integration of Eversense® CGM and the Eversense
Remote Patient Monitoring (RPM) solution within St. Louis-based
Mercy health care system, a major healthcare provider serving three
million patients annually, including 30,000 potential CGM users.
The collaboration aims to enhance patient outcomes and reduce
healthcare costs for users and is being designed as a model to aid
health systems in managing large at-risk populations effectively
and economically
- Received iCGM (integrated CGM) designation for the Eversense
System from the U.S, Food and Drug Administration, making Eversense
the first fully implantable continuous glucose monitoring system
that can now be integrated with insulin pumps as part of an
automated insulin delivery system
- Filed a 510(k) submission with the FDA for the next generation
Eversense 365-day system for iCGM designation
“It has been a very productive start to the year for Senseonics
as we continue to expand the features of Eversense to benefit more
people with diabetes. The Eversense platform now sits in its
strongest position ever, following receipt of the iCGM designation,
the filing of our next-generation 365-day system with the FDA, and
the announcements of our Eversense RPM and collaboration with
Mercy,” said Tim Goodnow, PhD, President and Chief Executive
Officer of Senseonics. “We are proud Eversense was chosen by one of
the largest and most innovative health systems in the country to
monitor risk and proactively treat both their type 1 and type 2
patients. Integrating the longest-lasting CGM into a diabetes
population management program, we are confident that Eversense can
help improve patient outcomes and lower the cost of care for the
thousands of patients in the Mercy system who could benefit from
CGM.”
First Quarter 2024 Results:
Total revenue for the first quarter of 2024 was $5.1 million
compared to $4.1 million for the first quarter of 2023. U.S.
revenue was $3.7 million in the first quarter of 2024 compared to
$2.1 million in the prior year period, and revenue outside the U.S.
was $1.4 million in the first quarter of 2024 compared to $2.0
million in the prior year period.
First quarter 2024 gross profit of $0.3 million decreased from
$0.4 million for the first quarter of 2023. The decrease in gross
margin was primarily driven by an increase in fixed manufacturing
costs compared to the prior year quarter.
First quarter 2024 sales and marketing and general and
administrative expenses increased by $0.4 million year-over-year,
to $8.1 million. The increase was primarily driven by costs related
to marketing initiatives.
First quarter 2024 research and development expenses decreased
by $2.0 million year-over-year, to $10.4 million. The decrease was
primarily due to the completion of the ENHANCE pivotal trial.
Net loss was $18.9 million, or $0.03 per share, in the first
quarter of 2024 compared to net income of $1.3 million, or $0.00
per share, in the first quarter of 2023. Net income decreased by
$20.2 million due to the accounting for embedded derivatives, fair
value adjustments and the exchange of a portion of the 2025
notes.
First Half 2024 Financial Outlook
Senseonics continues to expect first half of 2024 global net
revenue to be $10 million, representing growth of approximately 16%
compared to the first half of 2023.
The Company plans to provide its full year financial outlook at
an investor event to be scheduled during the upcoming American
Diabetes Association Scientific Sessions on June 21-24, 2024 in
Orlando, Florida.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, May 13, 2024, 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: 7182212
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 "First Half 2024 Financial Outlook," statements
regarding the integration of the Eversense CGM and the Eversense
RPM solution within the Mercy health care system, the adoption or
growth of Eversense, and the potential to enhance patient outcomes
and reduce healthcare costs, statements regarding Senseonics’
product pipeline, expected regulatory approvals and timing of the
potential commercial launch of the 365-day product, 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 execution of the independent business unit of
Ascensia Diabetes Care, the Company’s commercialization partner for
Eversense, and other commercial initiatives, uncertainties in
insurer, regulatory and administrative processes and decisions,
uncertainties inherent in the development and registration of new
technology and solutions, uncertainties inherent in finalizing
integration and commercial terms with new partners and other third
parties, uncertainties inherent in the ongoing commercialization of
the Eversense product and the expansion of the Eversense product
and a new RPM solution, uncertainties relating to the current
economic environment and such other factors as are set forth in the
risk factors detailed in Senseonics' Quarterly Report on Form 10-Q
for the quarter ended March 31, 2024 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)
March 31,
December 31,
2024
2023
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
90,544
$
75,709
Restricted cash
316
—
Short term investments, net
8,169
33,747
Accounts receivable, net
1,001
808
Accounts receivable, net - related
parties
2,750
3,724
Inventory, net
7,963
8,776
Prepaid expenses and other current
assets
7,434
7,266
Total current assets
118,177
130,030
Deposits and other assets
6,903
7,006
Property and equipment, net
1,436
1,184
Total assets
$
126,516
$
138,220
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
675
$
4,568
Accrued expenses and other current
liabilities
10,034
11,744
Accrued expenses and other current
liabilities, related parties
1,071
945
Note payable, current portion, net
17,937
—
Derivative liability, current portion
102
—
Total current liabilities
29,819
17,257
Long-term debt and notes payables, net
33,965
41,195
Derivative liabilities
—
102
Other liabilities
6,114
6,214
Total liabilities
69,898
64,768
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 March 31, 2024 and December 31, 2023
37,656
37,656
Total temporary equity
37,656
37,656
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value per share;
900,000,000 shares authorized as of March 31, 2024 and December 31,
2023; 530,817,549 shares and 530,364,237 shares issued and
outstanding as of March 31, 2024 and December 31, 2023
530
530
Additional paid-in capital
906,569
904,535
Accumulated other comprehensive loss
(2
)
(11
)
Accumulated deficit
(888,135
)
(869,258
)
Total stockholders’ equity
18,962
35,796
Total liabilities and stockholders’
equity
$
126,516
$
138,220
Senseonics Holdings,
Inc.
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive Income
(Loss)
(in thousands, except share
and per share data)
Three Months Ended
March 31,
2024
2023
Revenue, net
$
589
$
313
Revenue, net - related parties
4,458
3,824
Total revenue
5,047
4,137
Cost of sales
4,712
3,723
Gross profit
335
414
Expenses:
Research and development expenses
10,438
12,405
Selling, general and administrative
expenses
8,129
7,718
Operating loss
(18,232
)
(19,709
)
Other (expense) income, net:
Interest income
1,384
1,108
Exchange related gain, net
—
18,776
Interest expense
(2,047
)
(4,652
)
Gain on change in fair value of
derivatives
—
5,778
Other income
18
23
Total other (expense) income, net
(645
)
21,033
Net (Loss) Income
(18,877
)
1,324
Other comprehensive income
Unrealized gain on marketable
securities
9
458
Total other comprehensive gain
9
458
Total comprehensive (loss) income
$
(18,868
)
$
1,782
Basic net (loss) income per common
share
$
(0.03
)
$
0.00
Basic weighted-average shares
outstanding
614,588,546
497,473,222
Diluted net (loss) per common share
$
(0.03
)
$
0.00
Diluted weighted-average shares
outstanding
614,588,546
540,532,813
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version on businesswire.com: https://www.businesswire.com/news/home/20240513223963/en/
Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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