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
second quarter ended June 30, 2024.
Recent Highlights & Accomplishments:
- Generated revenue of $4.9 million in the second quarter of
2024, representing growth of more than 18% compared to the prior
year period
- FDA review of the 510(k) submission for the next-generation
365-day Eversense® system and operational readiness activities
continue to advance for planned fourth quarter 2024 product
launch
- Continued to advance the collaboration with Mercy healthcare
system on the first-of-its-kind initiative for a large-scale
implementation of Eversense and the launch of our remote patient
monitoring service, aimed at improving clinical outcomes and
reducing healthcare costs, with initial insertions planned for Q3
2024.
- Established Eon Care Services, a wholly owned subsidiary of
Senseonics, to provide Eversense insertion procedures and training
to complement the Nurse Practitioner Group in order to support and
expand access to Eversense
- Began first-in-human testing for the Gemini System, a fully
implantable self-powering system designed to include a flash
glucose monitor with no on-body component for people with type 2
diabetes
“During the second quarter, the Eversense user base in the U.S.
expanded and we advanced key strategic initiatives to position the
Company to successfully launch the 365-day Eversense system in the
fourth quarter, pending anticipated FDA clearance,” said Tim
Goodnow, PhD, President and Chief Executive Officer of Senseonics.
“We are focused on executing the integration of the Eversense CGM +
RPM solution with Mercy, preparing for launch of the 365-day
Eversense product, and the progression of exciting offerings in our
development pipeline. We envision these initiatives serving as the
foundation for significant future growth.”
Second Quarter 2024 Results:
Total revenue for the second quarter of 2024 was $4.9 million
compared to $4.1 million for the second quarter of 2023. U.S.
revenue was $3.0 million in the second quarter of 2024 compared to
$1.8 million in the prior year period, and revenue outside the U.S.
was $1.9 million in the second quarter of 2024 compared to $2.3
million in the prior year period.
Second quarter 2024 gross profit of $0.3 million decreased from
$0.4 million for the second quarter of 2023. The decrease in gross
margin was primarily driven by an increase in fixed manufacturing
costs compared to the prior year quarter.
Second quarter 2024 sales and marketing and general and
administrative expenses increased by $1.5 million year-over-year,
to $9.0 million. The increase was primarily driven by expenses to
expand commercial initiatives for Eon Care Services and the Mercy
collaboration.
Second quarter 2024 research and development expenses decreased
by $2.0 million year-over-year, to $10.8 million. The decrease was
primarily due to the completion of the 365-day sensor pivotal
trial.
Net loss was $20.3 million, or $0.03 per share, in the second
quarter of 2024 compared to net loss of $20.4 million, or $0.04 per
share, in the second quarter of 2023. Net income increased by $0.1
million due to the reduction in research and development
expenses.
Cash, cash equivalents, restricted cash and short-term
investments were $84.9 million and outstanding indebtedness was
$56.2 million as of June 30, 2024.
Full Year 2024 Financial Outlook
Senseonics continues to expect full year 2024 global net revenue
to be in the range of $22 million to $24 million. The full year
2024 financial outlook assumes more than doubling the U.S. new
patient starts and increasing the global installed base by
approximately 50% in 2024 compared to 2023. Inventory dynamics
associated with the 365-day product launch are expected to impact
third quarter product sales, with sales expected to accelerate in
the fourth quarter based on 365-day product sales and the Mercy
collaboration. Cash utilization in 2024 is expected to be
consistent with 2023 at approximately $70 million.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, August 8, 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: 4740206
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 system Eversense® E3
includes 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, assumptions related to U.S. new patient starts and the
global installed base under "Full Year 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)
June 30,
December 31,
2024
2023
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
34,853
$
75,709
Restricted cash
318
—
Short term investments, net
49,774
33,747
Accounts receivable, net
1,277
808
Accounts receivable, net - related
parties
3,075
3,724
Inventory, net
7,215
8,776
Prepaid expenses and other current
assets
6,502
7,266
Total current assets
103,014
130,030
Deposits and other assets
5,241
7,006
Property and equipment, net
3,306
1,184
Total assets
$
111,561
$
138,220
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
1,331
$
4,568
Accrued expenses and other current
liabilities
11,916
11,744
Accrued expenses and other current
liabilities, related parties
1,226
945
Note payable, current portion, net
18,642
—
Total current liabilities
33,115
17,257
Long-term debt and notes payables, net
34,202
41,195
Derivative liabilities
—
102
Other liabilities
6,010
6,214
Total liabilities
73,327
64,768
Preferred stock and additional
paid-in-capital, subject to possible redemption: $0.001 par value
per share; 12,000 shares authorized and 12,000 shares issued and
outstanding as of June 30, 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;
1,400,000,000 shares and 900,000,000 shares authorized as of June
30, 2024 and December 31, 2023; 535,277,362 shares and 530,364,237
shares issued and outstanding as of June 30, 2024 and December 31,
2023
535
530
Additional paid-in capital
908,472
904,535
Accumulated other comprehensive loss
(7
)
(11
)
Accumulated deficit
(908,422
)
(869,258
)
Total stockholders’ equity
578
35,796
Total liabilities and stockholders’
equity
$
111,561
$
138,220
Senseonics Holdings,
Inc.
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share
and per share data)
Three Months Ended
Six Months Ended
June 30,
June 30,
2024
2023
2024
2023
Revenue, net
$
778
$
437
$
1,367
$
750
Revenue, net - related parties
4,087
3,689
8,545
7,513
Total revenue
4,865
4,126
9,912
8,263
Cost of sales
4,567
3,709
9,279
7,433
Gross profit
298
417
633
830
Expenses:
Research and development expenses
10,800
12,830
21,238
25,235
Selling, general and administrative
expenses
8,991
7,455
17,119
15,173
Operating loss
(19,493
)
(19,868
)
(37,724
)
(39,578
)
Other (expense) income, net:
Interest income
1,190
1,311
2,574
2,420
Exchange related gain, net
—
—
—
18,776
Interest expense
(2,085
)
(2,310
)
(4,133
)
(6,962
)
Gain on change in fair value of
derivatives
102
289
102
6,067
Other (expense) income
(1
)
155
17
178
Total other (expense) income, net
(794
)
(555
)
(1,440
)
20,479
Net Loss
(20,287
)
(20,423
)
(39,164
)
(19,099
)
Other comprehensive loss
Unrealized (loss) gain on marketable
securities
(5
)
100
4
558
Other comprehensive (loss) gain
(5
)
100
4
558
Total comprehensive loss
$
(20,292
)
$
(20,323
)
$
(39,160
)
$
(18,541
)
Basic net loss per common share
$
(0.03
)
$
(0.04
)
$
(0.06
)
$
(0.04
)
Basic weighted-average shares
outstanding
616,585,664
567,125,022
615,587,105
532,499,776
Diluted net loss per common share
$
(0.03
)
$
(0.04
)
$
(0.06
)
$
(0.04
)
Diluted weighted-average shares
outstanding
616,585,664
567,125,022
615,587,105
532,499,776
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240808590774/en/
Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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