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 ended March 31, 2021.
Recent Highlights & Accomplishments:
- Generated first quarter 2021 revenue of $2.85 million primarily
driven by sales in the E.U.
- FDA review resumed in mid-April with the assignment of a lead
reviewer to the Eversense® 180-day PMA supplement application.
- “The PROMISE Study: An Evaluation of the Safety and Accuracy of
the Next Generation 180-Day Long-term Implantable Eversense CGM
System” to be presented in June at the ATTD and ADA conferences and
manuscript submitted to major diabetes journal.
- Teamed with University Hospitals Accountable Care Organization
as the first ACO to adopt Eversense for use in their Medicare
population.
- Strengthened balance sheet by raising $175 million of proceeds
from financing transactions.
- Decreased first quarter 2021 operating loss by $32.52 million
compared to the prior year period.
Advanced commercial collaboration with Ascensia Diabetes
Care
- Ascensia assumed full commercialization for the Eversense® CGM
in the U.S. on April 1, 2021 and for the Eversense® XL CGM in
select European markets on February 1, 2021.
- Ascensia completed the hiring and training of 25 Eversense
sales professionals in the U.S. and additional support roles
including inside sales, clinical support, market access and
customer care professionals in addition to the existing commercial
organization of over 250 professionals in European countries active
with Eversense.
- Ascensia launched a U.S. direct-to-consumer advertising
campaign for Eversense in early Q2.
“We are very pleased with our start to 2021 including the
transfer of worldwide Eversense commercial activity to Ascensia. In
the U.S. there are now 25 sales representatives trained and
actively calling on existing Eversense accounts and targeting top
insulin prescribers to further drive adoption of our CGM system,”
said Tim Goodnow, PhD, President and Chief Executive Officer of
Senseonics. “As part of their U.S. commercial efforts, Ascensia has
launched a direct-to-consumer ad campaign aimed at raising
awareness of the differentiating capabilities and benefits of
Eversense that in most cases is offered at a comparable annual
co-pay to patients’ other choices. We are excited that this
collaboration enables further patient access to the only long-term
implantable CGM solution with a sensor that lasts for months not
days.”
First Quarter 2021 Results:
Total revenue for the quarter was $2.85 million compared to
$0.04 million for the first quarter of 2020. U.S. revenue was $0.31
million and revenue outside the U.S. was $2.53 million.
First quarter 2021 gross profit increased by $20.16 million
year-over-year, to $0.53 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.
First quarter 2021 sales and marketing expenses decreased by
$9.53 million year-over-year, to $1.61 million. The decrease was
primarily due to the strategic changes in our go-to-market strategy
with the Ascensia global collaboration.
First quarter 2021 research and development expenses decreased
by $2.11 million year-over-year, to $5.26 million. The decrease was
primarily driven by lower clinical study costs and personnel
related expenses.
First quarter 2021 general and administrative expenses decreased
by $0.72 million year-over-year, to $4.97 million. The decrease was
primarily due to a decrease in personnel related costs.
Net loss was $249.51 million, or $0.68 per share, in the first
quarter of 2021, compared to $42.59 million, or $0.21 per share, in
the first quarter of 2020. Net loss increased by $206.92 million
due to a $239.44 million increase to other expenses primarily
related to non-cash accounting charges resulting from the
accounting for embedded derivatives related to certain of the
company financings, partially offset by a $32.52 million decrease
in loss from operations.
As of March 31, 2021, cash and cash equivalents were $178.6
million and outstanding indebtedness was $110.6 million.
2021 Financial Outlook
The company continues to expect that 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, May 13, 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: 6107459
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
March 31,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
178,610
$
18,005
Restricted cash
—
200
Accounts receivable, net
334
565
Accounts receivable - related parties
1,352
2,421
Inventory, net
6,584
5,281
Prepaid expenses and other current
assets
4,451
3,774
Total current assets
191,331
30,246
Option
1,104
1,886
Deposits and other assets
2,049
2,229
Property and equipment, net
1,463
1,557
Total assets
$
195,947
$
35,918
Liabilities and Stockholders’
Deficit
Current liabilities:
Accounts payable
$
930
$
1,762
Accrued expenses and other current
liabilities
9,635
11,674
Term Loans, net
5,123
3,202
Total current liabilities
15,688
16,638
Long-term debt and notes payables, net
52,948
57,216
Derivative liabilities
243,018
62,119
Options
68,923
39,734
Other liabilities
1,269
1,483
Total liabilities
381,846
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 March 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; 427,914,984 and 265,582,688 shares
issued and outstanding as of March 31, 2021 and December 31,
2020
428
266
Additional paid-in capital
711,698
504,162
Accumulated deficit
(898,025
)
(648,511
)
Total stockholders' deficit
(185,899
)
(144,083
)
Total liabilities and stockholders’
deficit
$
195,947
$
35,918
Senseonics Holdings,
Inc.
Consolidated Statements of
Operations and Comprehensive Loss
(in thousands, except for
share and per share data)
Three Months Ended
March 31,
2021
2020
Revenue, net
$
487
$
31
Revenue, net - related parties
2,359
5
Total revenue
2,846
36
Cost of sales
2,320
19,670
Gross profit (loss)
526
(19,634
)
Expenses:
Sales and marketing expenses
1,613
11,145
Research and development expenses
5,255
7,362
General and administrative expenses
4,974
5,690
Operating loss
(11,316
)
(43,831
)
Other (expense) income, net:
Interest income
9
209
Loss on fair value adjustment of
options
(52,675
)
—
Gain (Loss) on extinguishment of debt and
option
330
(4,546
)
Interest expense
(4,058
)
(4,373
)
Gain (Loss) on change in fair value of
derivatives
(180,899
)
10,311
Impairment costs
(782
)
—
Other expense
(123
)
(363
)
Total other (expense) income, net
(238,198
)
1,238
Net loss
(249,514
)
(42,593
)
Total comprehensive loss
$
(249,514
)
$
(42,593
)
Basic and diluted net loss per common
share
$
(0.68
)
$
(0.21
)
Basic and diluted weighted-average shares
outstanding
364,274,433
203,745,974
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210513005931/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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