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 June 30, 2022.
Recent Highlights & Accomplishments:
- Achieved CE mark approval for the Eversense E3 6-month CGM
System with exceptional accuracy and reduced calibration planned
for European commercial launch in Q3
- Completed transition of U.S. commercial patients to the
Eversense E3 System--now only E3 systems are being shipped to U.S.
clinics, led by our global commercial partner, Ascensia Diabetes
Care.
- CMS issued G-codes became effective July 1, 2022, providing
access to E3 for all eligible Medicare beneficiaries
- Anthem (now Elevance Health) coverage decision adds 45 million
covered lives for Eversense E3 CGM
- Expanded data accessibility for patients to share and combine
their Eversense CGM data with other data sources and third party
integrated apps by making Eversense information available through
AppleHealth
- Generated revenue of $3.7 million in the second quarter of
2022
“The first half of the year was focused on building the
foundation to increase global patient adoption of our next
generation, longer duration E3 system, with the U.S. launch and the
European CE mark,” said Tim Goodnow, PhD, President and Chief
Executive Officer of Senseonics. “As we execute this plan, we
realized several second quarter accomplishments– inserting the
first U.S. E3 patients, building brand awareness, increasing
patient access through payor coverage policy transitions, scaling
up manufacturing and advancing 365-day system program feasibility
studies. We are encouraged by the early progress of the E3 launch
and look forward to continued collaboration with Ascensia to
deliver the benefits of Eversense to more patients and
providers.”
Second Quarter 2022 Results:
Total revenue for the second quarter of 2022 was $3.7 million,
compared to $3.3 million for the second quarter of 2021. U.S.
revenue was $1.2 million in the second quarter of 2022, compared to
$1.0 million in the prior year period, and revenue outside the U.S.
was $2.5 million in the second quarter of 2022, compared to $2.3
million in the prior year period.
Second quarter 2022 gross profit of $0.8 million increased from
$0.4 million in the second quarter of 2021.
Second quarter 2022 research and development expenses increased
by $2.2 million year-over-year, to $9.3 million. The increase was
primarily due to investments in product and clinical trials for
next generation technologies.
Second quarter 2022 selling, general and administrative expenses
decreased by $0.6 million year-over-year, to $8.6 million. The
decrease was primarily the result of reduced payroll expenses
related to stock-based compensation.
Net income was $104.2 million, or $0.22 per share, in the second
quarter of 2022 compared to a net loss of $180.3 million, or
($0.42) per share, in the second quarter of 2021. Net income
increased by $284.5 million due to the accounting for embedded
derivatives and fair value adjustments.
Cash, cash equivalents, short and long-term investments were
$150.5 million and outstanding indebtedness was $103.9 million as
of June 30, 2022.
2022 Financial Outlook
Senseonics reiterates the expectation for full year 2022 global
net revenue 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, August 9, 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:
Dial in number: 888-317-6003
Entry Number: 3659816
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 “2022 Financial Outlook,” statements about the
commercial launch of Eversense® E3, statements regarding increasing
patient access and adoption, statement 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
transition of commercialization responsibilities to Ascensia
Diabetes Care and its commercial initiatives, uncertainties in
insurer, regulatory and administrative processes and decisions,
uncertainties in the duration and severity of the COVID-19
pandemic, 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, 2021, the Quarterly
Report on Form 10-Q for the six months ended June 30, 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)
June 30,
December 31,
2022
2021
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
45,425
$
33,461
Short term investments, net
93,758
96,445
Accounts receivable, net
220
205
Accounts receivable, net - related
parties
3,824
1,768
Inventory, net
7,251
6,316
Prepaid expenses and other current
assets
7,818
6,218
Total current assets
158,296
144,413
Option
1,085
239
Deposits and other assets
3,347
1,086
Long term investments, net
11,334
51,882
Property and equipment, net
1,263
1,308
Total assets
$
175,325
$
198,928
Liabilities and Stockholders’ Equity
(Deficit)
Current liabilities:
Accounts payable
$
1,734
$
1,204
Accrued expenses and other current
liabilities
10,731
10,667
Accrued expenses and other current
liabilities- related parties
3,692
3,597
Note payable, current portion, net
14,874
—
Derivative liability, current portion
438
—
Term Loans, net
—
2,926
Total current liabilities
31,469
18,394
Long-term debt and notes payables, net
50,650
59,798
Derivative liabilities
54,737
236,291
Option
19,476
69,401
Other liabilities
3,052
579
Total liabilities
159,384
384,463
Commitments and contingencies
Stockholders’ equity (deficit):
Common stock, $0.001 par value per share;
900,000,000 shares authorized as of June 30, 2022 and December 31,
2021; 465,326,135 shares and 447,282,263 shares issued and
outstanding as of June 30, 2022 and December 31, 2021
465
447
Additional paid-in capital
776,640
765,215
Accumulated other comprehensive loss
(1,128
)
(212
)
Accumulated deficit
(760,036
)
(950,985
)
Total stockholders' equity (deficit)
15,941
(185,535
)
Total liabilities and stockholders’ equity
(deficit)
$
175,325
$
198,928
Senseonics Holdings,
Inc.
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive Income
(Loss)
(in thousands, except share
and per share data)
Three Months Ended
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Revenue, net
$
137
433
$
429
$
920
Revenue, net - related parties
3,577
2,856
5,767
5,215
Total revenue
3,714
3,289
6,196
6,135
Cost of sales
2,890
2,897
4,845
5,217
Gross profit
824
392
1,351
918
Expenses:
Research and development expenses
9,299
7,107
17,103
12,362
Selling, general and administrative
expenses
8,561
9,175
16,445
15,762
Operating loss
(17,036
)
(15,890
)
(32,197
)
(27,206
)
Other income (expense), net:
Interest income
241
247
334
256
Gain (Loss) on fair value adjustment of
option
28,224
(35,730
)
49,925
(88,405
)
Gain on extinguishment of debt and
option
—
—
—
330
Interest expense
(4,510
)
(4,034
)
(9,005
)
(8,092
)
Gain (Loss) on change in fair value of
derivatives
96,548
(124,361
)
181,117
(305,260
)
Net gain (impairment)
816
(381
)
846
(1,163
)
Other expense
(52
)
(157
)
(71
)
(280
)
Total other income (expense), net
121,267
(164,416
)
223,146
(402,614
)
Net Income (Loss)
104,231
(180,306
)
190,949
(429,820
)
Other comprehensive loss
Unrealized loss on marketable
securities
(291
)
(16
)
(916
)
(16
)
Total other comprehensive loss
(291
)
(16
)
(916
)
(16
)
Total comprehensive income (loss)
$
103,940
$
(180,322
)
$
190,033
$
(429,836
)
Basic net income (loss) per common
share
$
0.22
(0.42
)
$
0.42
$
(1.08
)
Basic weighted-average shares
outstanding
464,133,903
431,840,854
460,061,022
398,244,296
Diluted net income (loss) per common
share
$
(0.03
)
(0.42
)
$
(0.06
)
$
(1.08
)
Diluted weighted-average shares
outstanding
601,330,959
431,840,854
604,342,540
398,244,296
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220809005985/en/
Investor Contact Philip Taylor Investor Relations
415-937-5406 Investors@senseonics.com
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