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 and full year ended December 31, 2023.
Recent Highlights & Accomplishments:
- Generated revenue of $8.0 million in the fourth quarter of
2023, representing growth of 44% compared to the prior year period
and revenue of $22.4 million in the full year 2023, representing
growth of 37% compared to 2022
- Brian Hansen appointed President of CGM at Ascensia Diabetes
Care, leading the newly created independent business unit and its
dedicated resources and reporting directly to PHC Group, to
strengthen Eversense commercial execution
- Medicare expanded access to the Eversense E3 CGM System through
implementation of Local Coverage Determinations by three Medicare
Administrative Contractors (MACs) providing coverage for
implantable CGM for basal only patients
- Completed the ENHANCE pivotal trial in preparation of the FDA
regulatory filing for the 365-day Eversense system expected to be
filed in the coming weeks
- Drew an additional $10.0 million on the loan facility with
Hercules Capital, Inc. further strengthening the balance sheet
“2023 was a successful year across the business for Senseonics.
We completed the ENHANCE clinical trial and data analysis to
support the imminent FDA submission for our 365-day system, secured
expanded Eversense coverage from UnitedHealthcare and Medicare, and
strengthened our balance sheet to provide additional financial
flexibility to continue executing our business plan,” said Tim
Goodnow, PhD, President and Chief Executive Officer of Senseonics.
“We are excited about Ascensia’s appointment of Brian Hansen, an
industry veteran in the diabetes space with a successful track
record of commercializing advanced technologies, who we believe can
lead the acceleration of adoption of Eversense. We believe the
robust Eversense product innovation cycle, including expected
approvals of the iCGM designation for the 180-day product and the
365-day product and the anticipated commercial launch of the
365-day product in Q4, will offer substantial additional benefits
to diabetes patients and positions Senseonics for its next phase of
growth.”
Fourth Quarter 2023 Results:
Total revenue for the fourth quarter of 2023 was $8.0 million
compared to $5.6 million for the fourth quarter of 2022. U.S.
revenue was $6.1 million in the fourth quarter of 2023 compared to
$3.6 million in the prior year period, and revenue outside the U.S.
was $1.9 million in the fourth quarter of 2023 compared to $2.0
million in the prior year period.
Fourth quarter 2023 gross profit of $1.1 million increased from
$0.6 million for the fourth quarter of 2022. The increase in gross
margin was primarily driven by an increase in revenue as volumes
increased.
Fourth quarter 2023 sales and marketing and general and
administrative expenses decreased by $0.5 million year-over-year,
to $7.3 million. The reduction was the result of efforts to manage
other general and administrative costs across the organization.
Fourth quarter 2023 research and development expenses decreased
by $0.9 million year-over-year, to $10.7 million. The decrease was
primarily due to the completion of the ENHANCE pivotal trial.
Net loss was $17.2 million, or $0.03 per share, in the fourth
quarter of 2023 compared to net income of $11.6 million, or $0.02
per share, in the fourth quarter of 2022. Net income decreased by
$28.8 million due to the accounting for embedded derivatives, fair
value adjustments and the exchange of a portion of the 2025
notes.
Full Year 2023 Results:
Total revenue for 2023 was $22.4 million compared to $16.4
million in 2022. U.S. revenue was $14.1 million in 2023 compared to
$7.5 million in the prior year, and revenue outside the U.S. was
$8.3 million in 2023 compared to $8.9 million in the prior year
period.
Gross profit for 2023 was $3.1 million, an increase from $2.7
million in 2022. The increase in gross margin was primarily driven
by an increase to revenue as volumes increased.
Sales and marketing and general and administrative expenses for
2023 decreased by $1.7 million year-over-year, to $29.9 million.
The reduction was the result of efforts to manage other general and
administrative costs across the organization.
Research and development expenses for 2023 increased by $9.0
million year-over-year, to $48.8 million. The increase was
primarily due to investments in our product pipeline for
development and clinical trials of next generation
technologies.
Net loss was $60.4 million, or $0.11 per share, in 2023 compared
to net income of $142.1 million, or $0.30 per share, in 2022. Net
income decreased by $202.5 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
$109.4 million and outstanding indebtedness was $46.1 million as of
December 31, 2023.
First Half 2024 Financial Outlook
Senseonics expects first half of 2024 global net revenue to be
nearly $10 million, representing growth of approximately 16%
compared to the first half of 2023. Senseonics plans to provide its
full year 2024 financial outlook in the second quarter following a
comprehensive analysis of the current commercial dynamics by the
new leadership at the Ascensia Diabetes Care CGM business unit and
an updated view on product approval and launch timing and
expectations.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, February 29, 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: 3711982
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
about the changes in leadership within the Ascensia’s CGM business
unit, potential strengthened Eversense® commercial execution,
statements regarding increasing patient access and patient and
provider adoption, 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 Ascensia’s independent business unit for the
commercialization of Eversense® E3 CGM system and other commercial
initiatives, 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, 2023, 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.
Consolidated Balance
Sheets
(in thousands, except for
share and per share data)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
75,709
$
35,793
Short term investments, net
33,747
108,222
Accounts receivable, net
808
127
Accounts receivable, net - related
parties
3,724
2,324
Inventory, net
8,776
7,306
Prepaid expenses and other current
assets
7,266
7,428
Total current assets
130,030
161,200
Deposits and other assets
7,006
3,108
Long term investments, net
—
12,253
Property and equipment, net
1,184
1,112
Total assets
$
138,220
$
177,673
Liabilities and Stockholders’ Equity
(Deficit)
Current liabilities:
Accounts payable
$
4,568
$
419
Accrued expenses and other current
liabilities
11,744
14,616
Accrued expenses and other current
liabilities, related parties
945
837
Note payable, current portion, net
—
15,579
Derivative liability, current portion
—
20
Total current liabilities
17,257
31,471
Long-term debt and notes payables, net
41,195
56,383
Derivative liabilities
102
52,050
Other liabilities
6,214
2,689
Total liabilities
64,768
142,593
Commitments and contingencies
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 December 31, 2023 and December 31, 2022
37,656
37,656
Total temporary equity
37,656
37,656
Stockholders’ equity (deficit):
Common stock, $0.001 par value per share;
900,000,000 shares authorized as of December 31, 2023 and December
31, 2022; 530,364,237 shares and 479,637,138 shares issued and
outstanding as of December 31, 2023 and December 31, 2022
530
480
Additional paid-in capital
904,535
806,488
Accumulated other comprehensive loss
(11
)
(678
)
Accumulated deficit
(869,258
)
(808,866
)
Total stockholders' equity (deficit)
35,796
(2,576
)
Total liabilities, temporary equity and
stockholders’ equity (deficit)
$
138,220
$
177,673
Senseonics Holdings,
Inc.
Consolidated Statements of
Operations and Comprehensive (Loss) Income
(in thousands, except for
share and per share data)
Years Ended
December 31,
2023
2022
Revenue, net
$
1,655
$
656
Revenue, net - related parties
20,735
15,733
Total revenue
22,390
16,389
Cost of sales
19,299
13,663
Gross profit
3,091
2,726
Expenses:
Research and development expenses
48,752
39,719
Selling, general and administrative
expenses
29,942
31,634
Operating loss
(75,603
)
(68,627
)
Other income (expense), net:
Interest income
5,362
1,824
Gain (Loss) on fair value adjustment of
option
—
43,745
Exchange related gain, net
14,109
—
Gain (Loss) on extinguishment of debt and
option
—
(101
)
Interest expense
(11,110
)
(18,703
)
Gain (Loss) on change in fair value of
derivatives
6,648
184,221
Impairment cost
—
(138
)
Other income (expense)
202
(102
)
Total other income, net
15,211
210,746
Net (Loss) Income
(60,392
)
142,119
Other comprehensive income (loss)
Unrealized gain (loss) on marketable
securities
667
(466
)
Total other comprehensive gain (loss)
667
(466
)
Total comprehensive (loss) income
$
(59,725
)
$
141,653
Basic net (loss) income per common
share
$
(0.11
)
$
0.30
Basic weighted-average shares
outstanding
567,974,492
467,952,475
Diluted net loss per common share
$
(0.11
)
$
(0.11
)
Diluted weighted-average shares
outstanding
567,974,492
618,205,605
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240229581974/en/
Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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