Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and commercialization
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, 2020.
Recent Highlights & Accomplishments:
- Generated fourth quarter 2020 revenue of $3.9 million primarily
driven by orders to support the European installed base up to the
Ascensia Diabetes Care commercial transition
- Raised $175 million of proceeds from equity offerings in the
first quarter of 2021 to strengthen the balance sheet
- Ascensia Diabetes Care initiated Eversense® sales and marketing
activities in Europe in select markets on February 1, 2021
- Eversense implantable CGM CPT codes were added to the 2021
Medicare Physician Fee Schedule improving national reimbursement
payment availability for implantable CGM systems and physician
services
- Reduced fourth quarter operating expenses by $13.8 million,
compared to the prior year period, resulting from the execution of
strategic cost reductions and the streamlined operational
focus
“We are very pleased with our fourth quarter results, our
commercial collaboration agreement with Ascensia, and the success
of our recent financings. These steps conclude a strategically
transformational year for Senseonics,” said Tim Goodnow, PhD,
President and Chief Executive Officer of Senseonics. “We believe
Ascensia’s commercial experience and global footprint will help
grow the market for Eversense in 2021 and beyond. We are working
with Ascensia to further expand commercial activity in the coming
months. These collaborative efforts include developing plans for
new programs designed to raise patient and provider awareness,
reduce patient cost, and continually expand global access for
Eversense.”
Fourth Quarter 2020 Results:
Total revenue for the quarter was $3.9 million compared to $9.0
million for the fourth quarter of 2019. U.S. revenue was $0.4
million and revenue outside the U.S. was $3.5 million.
Fourth quarter 2020 gross profit increased by $10.8 million
year-over-year, to $2.6 million. The positive gross margin in the
quarter was primarily due to the ability to fill resupply orders
with existing written off inventory as existing patient reinsertion
rates were above the expectations established in the first quarter
of 2020 amid the onset of the COVID-19 pandemic.
Fourth quarter 2020 sales and marketing expenses decreased by
$8.0 million year-over-year, to $3.0 million. The decrease was
primarily due to the recent changes in our go-to-market
strategy.
Fourth quarter 2020 research and development expenses decreased
by $5.1 million year-over-year, to $4.7 million. The decrease was
primarily driven by lower clinical study costs and personnel
related expenses.
Fourth quarter 2020 general and administrative expenses
decreased by $0.7 million year-over-year, to $5.2 million. The
decrease was primarily due to a decrease in miscellaneous general
and administrative costs.
Net loss was $101.6 million, or $0.41 per share, in the fourth
quarter of 2020, compared to $35.6 million, or $0.18 per share, in
the fourth quarter of 2019. Net loss increased by $66.0 million due
to a $90.6 million increase to other expenses primarily related to
non-cash accounting charges resulting from the accounting for
imbedded derivatives related to certain of the company financings,
partially offset by a $24.6 million decrease in loss from
operations.
Full Year 2020 Results:
Total revenue for 2020 was $4.9 million compared to total
revenue of $21.3 million in 2019. U.S. revenue was $1.1 million.
Revenue outside the U.S. was $3.8 million.
2020 gross profit increased by $2.1 million year-over-year, to
($17.4) million.
2020 sales and marketing expenses decreased by $29.0 million
year-over-year, to $20.6 million. The decrease was primarily due to
the recent changes in our go-to-market strategy.
2020 research and development expenses decreased by $18.0
million year-over-year, to $20.4 million. The decrease was
primarily driven by lower clinical study costs and personnel
related expenses.
2020 general and administrative expenses decreased by $2.4
million year-over-year, to $20.8 million. The decrease was
primarily due to decrease in other general and administrative
costs.
Net loss was $175.2 million, or $0.77 per share, in 2020,
compared to $115.5 million, or $0.61 per share, in 2019. Net loss
increased by $59.6 million due to a $111.2 million increase to
other expenses primarily related to non-cash accounting entries for
the company’s financings, partially offset by a $51.5 million
decrease in loss from operations.
As of December 31, 2020, cash, cash equivalents and restricted
cash were $18.2 million and outstanding indebtedness was $117.2
million. Cash, cash equivalents, and restricted cash rose to $187.3
million on January 31, 2021 following the equity financings
completed in the first quarter of 2021.
2021 Financial Outlook
Global net revenue to Senseonics for the full year 2021 is
expected to be in the range of $12.0 million to $15.0 million.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, March 4, 2021, 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: 3569931 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. is a medical technology company
focused on the design, development and commercialization of
transformational glucose monitoring products designed to help
people with diabetes confidently live their lives with ease.
Senseonics' CGM systems, Eversense® and Eversense® XL, 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 “2021 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 in the development and
regulatory approval processes for the 180-day Eversense product,
uncertainties inherent in the commercial launch and commercial
expansion of the product, uncertainties inherent in the transition
of commercialization responsibilities to Ascensia, 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, 2019, Senseonics’ Quarterly Report on Form
10-Q for the quarter ended September 30, 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.
Consolidated Balance Sheets (in thousands, except for share and per
share data)
December 31,
2020
2019
Assets
Current assets:
Cash and cash equivalents
$
18,005
$
95,938
Restricted cash
200
—
Accounts receivable, net
565
3,239
Accounts receivable - related parties
2,421
7,140
Inventory, net
5,281
16,929
Prepaid expenses and other current
assets
3,774
4,512
Total current assets
30,246
127,758
Option
1,886
—
Deposits and other assets
2,229
3,042
Property and equipment, net
1,557
2,001
Total assets
$
35,918
$
132,801
Liabilities and Stockholders’
Deficit
Current liabilities:
Accounts payable
$
1,762
$
4,285
Accrued expenses and other current
liabilities
11,674
18,636
Term Loans, net
3,202
43,434
2025 Notes, net
—
60,353
Total current liabilities
16,638
126,708
Long-term debt and notes payables, net
57,216
11,800
Derivative liabilities
62,119
664
Options
39,734
Other liabilities
1,483
2,278
Total liabilities
177,190
141,450
Preferred stock and additional
paid-in-capital, subject to possible redemption: $0.001 par value
per share; 3,000 shares and 0 shares issued and outstanding as of
December 31, 2020 and December 31, 2019
2,811
—
Total temporary equity
2,811
—
Commitments and contingencies
Stockholders’ deficit:
Common stock, $0.001 par value per share;
450,000,000 shares authorized; 265,582,688 and 203,452,812 shares
issued and outstanding as of December 31, 2020 and 2019
266
203
Additional paid-in capital
504,162
464,491
Accumulated deficit
(648,511
)
(473,343
)
Total stockholders' deficit
(144,083
)
(8,649
)
Total liabilities and stockholders’
deficit
$
35,918
$
132,801
Senseonics Holdings, Inc.
Consolidated Statements of Operations and Comprehensive Loss (in
thousands, except for share and per share data)
Years Ended
December 31,
2020
2019
2018
Revenue, net
$
1,368
$
4,924
$
2,039
Revenue, net - related parties
3,581
16,377
16,874
Total revenue
4,949
21,301
18,913
Cost of sales
22,315
40,749
27,059
Gross profit (loss)
(17,366
)
(19,448
)
(8,146
)
Expenses:
Sales and marketing expenses
20,550
49,555
27,730
Research and development expenses
20,413
38,430
31,863
General and administrative expenses
20,801
23,229
19,839
Operating loss
(79,130
)
(130,662
)
(87,578
)
Other (expense) income, net:
Interest income
175
1,933
2,001
Loss on fair value adjustment
(30,721
)
—
—
Loss on extinguishment of debt
(21,112
)
(398
)
—
Loss on issuance of debt & other
issuance costs
(12,706
)
—
—
Interest expense
(16,167
)
(11,799
)
(8,282
)
Debt issuance costs
(1,216
)
(3,344
)
—
Gain (Loss) on fair value and change in
fair value of derivatives
(11,641
)
29,232
209
Impairment costs
(2,339
)
Other expense
(311
)
(511
)
(321
)
Total other (expense) income, net
(96,038
)
15,113
(6,393
)
Net loss
(175,168
)
(115,549
)
(93,971
)
Total comprehensive loss
$
(175,168
)
$
(115,549
)
$
(93,971
)
Basic and diluted net loss per common
share
$
(0.77
)
$
(0.61
)
$
(0.14
)
Basic and diluted weighted-average shares
outstanding
227,912,358
188,754,160
157,429,145
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version on businesswire.com: https://www.businesswire.com/news/home/20210304006066/en/
Investor Contact Lynn Lewis or Philip Taylor Investor
Relations 415-937-5406 Investors@senseonics.com Senseonics
Media Contact: Mirasol Panlilio 301-556-1631
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