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, 2023.
Recent Highlights & Accomplishments:
- Generated revenue of $4.1 million in the first quarter of
2023.
- Ascensia Diabetes Care, Senseonics’ global commercial partner,
is expanding their U.S. salesforce to a planned nearly 50
professionals, compared to an average of approximately 20 during
2022.
- Initiated the enrollment of a pediatric cohort in the ENHANCE
trial evaluating the 365-day sensor configuration.
- Strengthened the balance sheet through financings from PHC
Holdings, which included PHC Holdings’ exchange of its $35 million
senior secured convertible notes for equity and an additional $15
million equity investment.
“In the first quarter, we made progress in our initiatives to
support global patient and provider adoption of Eversense,” said
Tim Goodnow, PhD, President and Chief Executive Officer of
Senseonics. “We believe continuing to work to drive commercial
awareness and access through the Ascensia collaboration, along with
advancing our technology pipeline, will drive future growth and
create durable shareholder value.”
First Quarter 2023 Results:
Total revenue for the first quarter of 2023 was $4.1 million
compared to $2.5 million for the first quarter of 2022. U.S.
revenue was $2.1 million in the first quarter of 2023 compared to
$0.8 million in the prior year period, and revenue outside the U.S.
was $2.0 million in the first quarter of 2023 compared to $1.7
million in the prior year period.
First quarter 2023 gross profit of $0.4 million decreased from
$0.5 million in gross profit for the first quarter of 2022.
First quarter 2023 sales and marketing and general and
administrative expenses decreased by $0.2 million year-over-year,
to $7.7 million. The decrease was primarily the result of a
reduction in spend related to personnel costs, general
administrative costs and selling and marketing consulting
services.
First quarter 2023 research and development expenses increased
by $4.6 million year-over-year, to $12.4 million. The increase was
due to investments for next generation technologies including
clinical studies activities, personnel related costs due to the
expansion of our research and development workforce, consulting,
contract fabrication and other R&D support services.
Net income was $1.3 million, or $0.00 per share, in the first
quarter of 2023 compared to a net income of $86.7 million, or $0.19
per share, in the first quarter of 2022. The change in net income
was the result of accounting for the exchange of the PHC notes,
embedded derivatives and fair value adjustments.
Cash, cash equivalents, short and long-term investments were
$136.6 million and outstanding indebtedness was $51.8 million as of
March 31, 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, May 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: 7018265
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 adoption, statements regarding advancing
development programs, 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, 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 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,
2023
2022
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
45,085
$
35,793
Short term investments, net
83,359
108,222
Accounts receivable, net
451
127
Accounts receivable, net - related
parties
2,953
2,324
Inventory, net
8,195
7,306
Prepaid expenses and other current
assets
6,293
7,428
Total current assets
146,336
161,200
Deposits and other assets
2,998
3,108
Long term investments, net
8,157
12,253
Property and equipment, net
1,042
1,112
Total assets
$
158,533
$
177,673
Liabilities and Stockholders’ Equity
(Deficit)
Current liabilities:
Accounts payable
$
646
$
419
Accrued expenses and other current
liabilities
12,808
14,616
Accrued expenses and other current
liabilities, related parties
823
837
Note payable, current portion, net
—
15,579
Derivative liability, current portion
—
20
Total current liabilities
14,277
31,471
Long-term debt and notes payables, net
37,479
56,383
Derivative liabilities
2,081
52,050
Other liabilities
2,576
2,689
Total liabilities
56,413
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 March 31, 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 March 31, 2023 and December 31,
2022; 479,780,414 shares and 479,637,138 shares issued and
outstanding as of March 31, 2023 and December 31, 2022
480
480
Additional paid-in capital
871,746
806,488
Accumulated other comprehensive loss
(220
)
(678
)
Accumulated deficit
(807,542
)
(808,866
)
Total stockholders’ equity (deficit)
64,464
(2,576
)
Total liabilities and stockholders’ equity
(deficit)
$
158,533
$
177,673
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 Income
(Loss)
(in thousands, except share
and per share data)
Three Months Ended
March 31,
2023
2022
Revenue, net
$
313
$
292
Revenue, net - related parties
3,824
2,189
Total revenue
4,137
2,481
Cost of sales
3,723
1,954
Gross profit
414
527
Expenses:
Research and development expenses
12,405
7,804
Selling, general and administrative
expenses
7,718
7,883
Operating loss
(19,709
)
(15,160
)
Other income (expense), net:
Interest income
1,108
93
Gain on fair value adjustment of
option
—
21,701
Exchange related gain, net
18,776
—
Interest expense
(4,652
)
(4,494
)
Gain on change in fair value of
derivatives
5,778
84,569
Impairment cost, net
—
30
Other income (expense)
23
(21
)
Total other income (expense), net
21,033
101,878
Net Income
1,324
86,718
Other comprehensive income (loss)
Unrealized gain (loss) on marketable
securities
458
(625
)
Total other comprehensive gain (loss)
458
(625
)
Total comprehensive income
$
1,782
$
86,093
Basic net income per common share
$
0.00
$
0.19
Basic weighted-average shares
outstanding
497,473,222
455,942,886
Diluted net income (loss) per common
share
$
0.00
$
(0.03
)
Diluted weighted-average shares
outstanding
540,532,813
605,198,839
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20230509006129/en/
Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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