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, 2021.
Recent Highlights & Accomplishments:
- Received approval from the Food and Drug Administration (FDA)
for the Eversense® E3 CGM System, offering patients:
- Fully implantable third generation sensor, with proprietary
sacrificial boronic acid (SBA) technology to enhance sensor
longevity, demonstrating a mean absolute relative difference (MARD)
of 8.5% in the PROMISE Study.
- Industry leading 6-month sensor wear duration, making Eversense
the longest lasting CGM system available, with essentially two
sensor insertion and removal procedures per year.
- Removable smart transmitter, held in place with a mild
silicone-based adhesive, providing discreet on-body vibratory
alerts and data transmission to a mobile app where glucose values,
trends, and alerts are displayed.
- Initiating E3 commercial launch in the U.S. at the beginning of
April, with active transition to the 6-month system and retirement
of the 90-day system
- Executed consignment agreements with health care professionals
to reduce acquisition barriers and expect to begin shipping product
next week
- Achieved 8 million additional covered lives with positive
coverage decisions from payors including Blue Cross Blue Shield of
Michigan, Medical Mutual of Ohio, and CareSource
- Received CE mark for Eversense NOW Remote Monitoring App for
Android users
“Following recent FDA approval, we are excited to make Eversense
E3, an industry leading 6-month sensor, available to patients and
health care providers in the U.S. in early April. Our partner
Ascensia is establishing a newly dedicated CGM commercial
organization to drive both adoption and awareness of the Eversense
E3,” said Tim Goodnow, PhD, President and Chief Executive Officer
of Senseonics. “We are excited to continue advancing our long-term
implantable sensor pipeline and IDE pivotal study approval for our
next-generation one year sensor this year.”
Fourth Quarter 2021 Results:
Total revenue for the fourth quarter was $4.0 million compared
to $3.9 million for the fourth quarter of 2020. This increase was
due to the transition of commercial responsibility for Eversense to
Ascensia and its orders for distribution in the European Union and
in the United States. For the fourth quarter comparisons, U.S.
revenue was $0.7 million in 2021 compared to $0.4 million in 2020,
and revenue outside the U.S. was $3.3 million in 2021 compared to
$3.5 million in 2020.
Fourth quarter 2021 gross loss declined by $3.1 million
year-over-year, to $0.5 million, as compared to a gross profit of
$2.6 million for the fourth quarter 2020 due to utilization of
previously written-off inventory in 2020.
Fourth quarter 2021 sales and marketing and general and
administrative expenses decreased by $2.4 million year-over-year,
to $5.8 million. The decrease was primarily the result of the
transition of sales support to Ascensia for the commercialization
of Eversense.
Fourth quarter 2021 research and development expenses increased
by $3.0 million year-over-year, to $7.7 million. The increase was
due to the expansion of the R&D workforce, and an increase in
clinical studies, lab supplies, and contractor expenses.
Net income was $84.4 million, or $0.19 per share, in the fourth
quarter of 2021, compared to a net loss of $101.6 million, or
($0.41) per share, in the fourth quarter of 2020. Net income
increased by $186.1 million due to the accounting for embedded
derivatives and fair value adjustments.
Full Year 2021 Results:
Total revenue for 2021 was $13.7 million compared to total
revenue of $4.9 million in 2020. U.S. revenue was $2.6 million in
2021 versus $1.1 million in 2020. Revenue outside the U.S. was
$11.1 million in 2021 versus $3.8 million in 2020. This increase
was due to the resumption of post-Covid sales and the transition of
commercial responsibility for Eversense to Ascensia. Ascensia
assumed commercial responsibilities for Eversense XL outside the
U.S. beginning on February 1, 2021 and for the 90-day Eversense
product in the U.S. during the second quarter of 2021.
Gross loss for 2021 improved by $16.6 million year-over-year, to
$0.8 million. The 2020 gross loss of $17.4 million was largely the
result of inventory impairment charges.
Sales and marketing and general and administrative expenses for
2021 decreased by $12.2 million year-over-year, to $29.2 million.
The decrease was primarily the result of the reduction in sales
support due to the transition of Eversense commercialization
responsibility to Ascensia.
Research and development expenses for 2021 increased by $6.8
million year-over-year, to $27.2 million. The increase was due to
the expansion of our R&D workforce and various R&D efforts
to improve our sensor & transmitter technology in 2021,
including the FDA approval of our Eversense E3 system.
Net loss was $302.5 million, or ($.72) per share, in 2021,
compared to $175.2 million, or ($0.77) per share, in 2020. Net loss
decreased by $127.3 million due to a $149.3 million decrease to
other expenses primarily related to the accounting for embedded
derivatives and fair value adjustments, partially offset by an
increase in expense for the extinguishment and issuance debt.
As of December 31, 2021, cash, cash equivalents, short and
long-term investments were $181.8 million and outstanding
indebtedness was $107.0 million.
2022 Financial Outlook
Global net revenue to Senseonics for the full year 2022 is
expected to be in the range of $14.0 million to $18.0 million.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, March 1, 2022, 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:
Live Webcast
Information:
Dial in number: 888-317-6003 Entry Number: 2775821 International
dial in: 412-317-6061
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. 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 “2022 Financial Outlook,” statements about the
potential benefits of the Ascensia commercialization and
collaboration agreement, including the ability of Ascensia to grow
the market for Eversense, the future increase in patient and
provider awareness of Eversense, reductions in patient costs and
expansion of access to Eversense, 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
transition of commercialization responsibilities to Ascensia and
its commercial initiatives, uncertainties in insurer, regulatory
and administrative processes and decisions, uncertainties in the
duration and severity of the COVID-19 pandemic, 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, 2020 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)
December 31, 2021
December 31, 2020
Assets
Current assets:
Cash and cash equivalents
$
33,461
$
18,005
Restricted cash
—
200
Short term investments, net
96,445
—
Accounts receivable, net
205
565
Accounts receivable - related parties
1,768
2,421
Inventory, net
6,316
5,281
Prepaid expenses and other current
assets
6,218
3,774
Total current assets
144,413
30,246
Option
239
1,886
Deposits and other assets
1,086
2,229
Long term investments, net
51,882
—
Property and equipment, net
1,308
1,557
Total assets
$
198,928
$
35,918
Liabilities and Stockholders’
Deficit
Current liabilities:
Accounts payable
$
1,204
$
1,762
Accrued expenses and other current
liabilities
14,264
11,674
Term Loans, net
2,926
3,202
Total current liabilities
18,394
16,638
Long-term debt and notes payables, net
59,798
57,216
Derivative liabilities
236,291
62,119
Option
69,401
39,734
Other liabilities
579
1,483
Total liabilities
384,743
177,190
Preferred stock and additional
paid-in-capital, subject to possible redemption: $0.001 par value
per share; 0 shares issued and outstanding as of December 31, 2021
and 3,000 shares issued and outstanding as of December 31, 2020
—
2,811
Total temporary equity
—
2,811
Commitments and contingencies
Stockholders’ deficit:
Common stock, $0.001 par value per share;
900,000,000 shares authorized; 447,282,263 and 265,582,688 shares
issued and outstanding as of December 31, 2021 and December 31,
2020
447
266
Additional paid-in capital
765,215
504,162
Accumulated other comprehensive income,
net of tax
(212
)
—
Accumulated deficit
(950,985
)
(648,511
)
Total stockholders' deficit
(185,535
)
(144,083
)
Total liabilities and stockholders’
deficit
$
198,928
$
35,918
Senseonics Holdings,
Inc.
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share
and per share data)
Years Ended
December 31,
2021
2020
Revenue, net
$
1,394
$
1,368
Revenue, net - related parties
12,281
3,581
Total revenue
13,675
4,949
Cost of sales
14,486
22,315
Gross profit (loss)
(811
)
(17,366
)
Expenses:
Sales and marketing expenses
7,616
20,550
Research and development expenses
27,217
20,413
General and administrative expenses
21,538
20,801
Operating loss
(57,182
)
(79,130
)
Other income (expense), net:
Interest income
243
175
Loss on fair value adjustment of
option
(53,152
)
(30,721
)
Gain (Loss) on extinguishment of debt and
option
330
(21,112
)
Loss on issuance of debt & other
issuance costs
—
(12,706
)
Interest expense
(16,720
)
(16,167
)
Debt issuance costs
—
(1,216
)
Gain (Loss) on change in fair value of
derivatives
(174,173
)
(11,641
)
Impairment cost
(1,647
)
(2,339
)
Other expense
(174
)
(311
)
Total other income (expense), net
(245,292
)
(96,038
)
Net Loss
(302,474
)
(175,168
)
Other comprehensive loss, net of tax
Unrealized loss on marketable
securities
(212
)
—
Total other comprehensive loss, net of
tax
(212
)
—
Total comprehensive loss, net of tax
$
(302,686
)
$
(175,168
)
Basic net loss per common share
$
(0.72
)
$
(0.77
)
Basic weighted-average shares
outstanding
422,321,023
(227,912,358
)
Diluted net loss per common share
$
(0.72
)
$
(0.77
)
Diluted weighted-average shares
outstanding
422,321,023
227,912,358
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220301006126/en/
Investor Contact Philip Taylor Investor Relations
415-937-5406 Investors@senseonics.com
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